Aggressive Non-Hodgkin Lymphoma, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Chronic Lymphocytic Leukemia, Loss of Chromosome 17p, Myelodysplastic/Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma, Prolymphocytic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Aggressive Adult Non-Hodgkin Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Hodgkin Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Waldenstrom Macroglobulinemia
Conditions
Brief summary
This phase II trial studies how well donor atorvastatin treatment works in preventing severe graft-versus-host disease (GVHD) after nonmyeloablative peripheral blood stem cell (PBSC) transplant in patients with hematological malignancies. Giving low doses of chemotherapy, such as fludarabine phosphate, before a donor PBSC transplantation slows the growth of cancer cells and may also prevent the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also cause an immune response against the body's normal cells (GVHD). Giving atorvastatin to the donor before transplant may prevent severe GVHD.
Detailed description
PRIMARY OBJECTIVES: I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD. SECONDARY OBJECTIVES: I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe. OUTLINE: DONOR: Donors receive atorvastatin orally (PO) once daily (QD) beginning on day -14 and continuing until the last day of stem cell collection. NONMYELOABLATIVE PREPARATIVE REGIMEN: If the patient is enrolled on an investigational nonmyeloablative hematopoietic cell transplant (HCT) protocol or a treatment plan that uses a nonmyeloablative preparative regimen with postgrafting cyclosporine (CSP) that does not use acute GVHD as its primary endpoint, the preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan (Protocol 2546 serves as adjunct protocol). If the patient is not enrolled on an investigational nonmyeloablative HCT protocol or a treatment plan that uses a nonmyeloablative preparative regimen, Protocol 2546 serves as an independent primary treatment protocol. The preparative regimen and immunosuppression after transplant is as follows: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27. After completion of study treatment, patients are followed up at 1 year and then annually thereafter.
Interventions
Given PO
Given PO
Given IV
Correlative studies
Given PO or IV
Undergo nonmyeloablative allogeneic PBSC transplant
Undergo nonmyeloablative allogeneic PBSC transplant
Undergo TBI
Sponsors
Study design
Eligibility
Inclusion criteria
IF PROTOCOL 2546 SERVES AS AN ADJUNCT PROTOCOL, THE PATIENTS ONLY NEEDS TO MEET INCLUSION CRITERIA 1 THROUGH 5A * Availability of human leukocyte antigen (HLA)-identical sibling donor * Transplantation with PBSC * CSP-based postgrafting immunosuppression * Willingness to give informed consent * Patient is enrolled on an investigational nonmyeloablative HCT protocol or a nonmyeloablative treatment plan with postgrafting CSP that does not use acute GVHD as its primary endpoint (protocol 2546 serves as adjunct protocol); OR * Patient is not enrolled on an investigational nonmyeloablative HCT protocol, in which case protocol 2546 serves as an independent primary treatment protocol and the patient must meet the following inclusion and
Exclusion criteria
* Patients must have a hematologic malignancy treatable by nonmyeloablative HCT; the following diseases will be permitted although other diagnoses can be considered if approved by Patient Care Conference (PCC) and the principal investigator: * Aggressive non-Hodgkin lymphomas (NHL) and other histologies such as diffuse large B-cell NHL - not eligible for autologous HCT, not eligible for high-dose allogeneic HCT, or after failed autologous HCT * Mantle-cell NHL - may be treated in first complete remission (CR); (diagnostic lumbar puncture \[LP\] required pre-transplant) * Low grade NHL - with \< 6 month duration of CR between courses of conventional therapy * Chronic lymphocytic leukemia (CLL) - must have either: * Failed to meet National Cancer Institute (NCI) Working Group criteria for complete or partial response after therapy with a regimen containing fludarabine phosphate (FLU) (or another nucleoside analog) or experience disease relapse within 12 months after completing therapy with a regimen containing FLU (or another nucleoside analog) * Failed FLU-cyclophosphamide (CY)-Rituximab (FCR) combination chemotherapy at any time point; or * Have 17p deletion cytogenetic abnormality; patients should have received induction chemotherapy but could be transplanted in 1st CR * Patients with a diagnosis of CLL (or small lymphocytic lymphoma) that progresses to prolymphocytic leukemia (PLL); or * Patients with T-cell CLL or PLL * Hodgkin lymphoma - must have received and failed frontline therapy * Multiple myeloma - must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted * Acute myeloid leukemia (AML) - must have \< 5% marrow blasts at the time of transplant * Acute lymphocytic leukemia (ALL) - must have \< 5% marrow blasts at the time of transplant * Chronic myeloid leukemia (CML) - Patients will be accepted if they have shown intolerance to tyrosine kinase inhibitors or are beyond first chronic phase (CP1) and if they have received previous myelosuppressive chemotherapy or HCT, and have \< 5% marrow blasts at time of transplant * Myelodysplasia (MDS)/myeloproliferative syndrome (MPS) - Patients must have \< 5% marrow blasts at time of transplant * Waldenstrom's macroglobulinemia - must have failed 2 courses of therapy * Patients \< 12 years of age must be approved by the principal investigator and by a relevant patient review committee, such as the Fred Hutchinson Cancer Research Center (FHCRC) Patient Care Conference (PCC) * Patients must have either relapsed after previous high-dose chemotherapy and autologous or allogeneic HCT, or else be ineligible for such an approach due to age, failure to mobilize sufficient hematopoietic stem cells, medical comorbidities, or patient refusal * Patients who refuse to be treated on a conventional autologous or allogeneic HCT protocol * DONOR: Age \>= 18 years * DONOR: HLA genotypically identical sibling * DONOR: Willingness to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant | 100 days post-transplant | Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy | 1 Year post-transplant | Number of patients requiring systemic immunosuppressive therapy other than those used for prophylaxis and initial therapy. |
| Number of Patients With Chronic Extensive GVHD | 1 Year post-transplant | Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. Patients were evaluated as described in the National Institutes of Health (NIH) consensus project guidelines. |
| Number of Patients With Recurrent or Progressive Malignancy | 1 Year post-transplant | CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL, MDS \>5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease. CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions. |
| Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD) | 100 days post-transplant | Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death |
| Number of Patients Surviving Overall | 1 Year post-transplant | Number of patients surviving overall post-transplant |
| Number of Donors Discontinuing Atorvastatin Due to Toxicity | Prior to stem cell collection | The number of donors who prematurely discontinue atorvastatin therapy due to toxicity. Donors will be assessed for the following events: * Musculoskeletal and connective tissue disorders: grade 2-5 * Hepatobiliary disorders: grade 2-5 * Other unexpected events thought related to the use of atorvastatin; grade 2-5 In cases where the NCI criteria do not apply, intensity will be defined as: * Mild: awareness of symptom or sign, but easily tolerated * Moderate: discomfort is enough to cause interference with normal activities * Severe: inability to perform normal daily activities * Life threatening: immediate risk of death from the reaction as it occurred |
| Number of Non-relapse Mortalities | 1 Year post-transplant | Number of patients who died without relapsed/progressive disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary - Reg A (Flu/TBI) NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0.
TRANSPLANT: Patients undergo donor PBSC transplant on day 0.
POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27. | 30 |
| Primary - Reg B (TBI Alone) NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0.
TRANSPLANT: Patients undergo donor PBSC transplant on day 0.
POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27. | 5 |
| Adjunct NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan.
POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27. | 12 |
| Total | 47 |
Baseline characteristics
| Characteristic | Primary - Reg A (Flu/TBI) | Primary - Reg B (TBI Alone) | Adjunct | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 1 Participants | 3 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 4 Participants | 9 Participants | 26 Participants |
| Age, Continuous | 65.4 years | 54 years | 62.35 years | 64.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 5 Participants | 12 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 4 Participants | 10 Participants | 39 Participants |
| Region of Enrollment United States | 30 participants | 5 participants | 12 participants | 47 participants |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Male | 20 Participants | 2 Participants | 9 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 29 | 2 / 5 | 3 / 12 |
| other Total, other adverse events | 6 / 29 | 1 / 5 | 2 / 12 |
| serious Total, serious adverse events | 1 / 29 | 0 / 5 | 0 / 12 |
Outcome results
Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant
Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
Time frame: 100 days post-transplant
Population: One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary - Reg A (Flu/TBI) | Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant | 2 Participants |
| Primary - Reg B (TBI Alone) | Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant | 0 Participants |
| Adjunct | Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant | 0 Participants |
Number of Donors Discontinuing Atorvastatin Due to Toxicity
The number of donors who prematurely discontinue atorvastatin therapy due to toxicity. Donors will be assessed for the following events: * Musculoskeletal and connective tissue disorders: grade 2-5 * Hepatobiliary disorders: grade 2-5 * Other unexpected events thought related to the use of atorvastatin; grade 2-5 In cases where the NCI criteria do not apply, intensity will be defined as: * Mild: awareness of symptom or sign, but easily tolerated * Moderate: discomfort is enough to cause interference with normal activities * Severe: inability to perform normal daily activities * Life threatening: immediate risk of death from the reaction as it occurred
Time frame: Prior to stem cell collection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary - Reg A (Flu/TBI) | Number of Donors Discontinuing Atorvastatin Due to Toxicity | 2 Participants |
| Primary - Reg B (TBI Alone) | Number of Donors Discontinuing Atorvastatin Due to Toxicity | 0 Participants |
| Adjunct | Number of Donors Discontinuing Atorvastatin Due to Toxicity | 1 Participants |
Number of Non-relapse Mortalities
Number of patients who died without relapsed/progressive disease.
Time frame: 1 Year post-transplant
Population: One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary - Reg A (Flu/TBI) | Number of Non-relapse Mortalities | 4 Participants |
| Primary - Reg B (TBI Alone) | Number of Non-relapse Mortalities | 1 Participants |
| Adjunct | Number of Non-relapse Mortalities | 0 Participants |
Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy
Number of patients requiring systemic immunosuppressive therapy other than those used for prophylaxis and initial therapy.
Time frame: 1 Year post-transplant
Population: One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary - Reg A (Flu/TBI) | Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy | 23 Participants |
| Primary - Reg B (TBI Alone) | Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy | 3 Participants |
| Adjunct | Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy | 4 Participants |
Number of Patients Surviving Overall
Number of patients surviving overall post-transplant
Time frame: 1 Year post-transplant
Population: One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary - Reg A (Flu/TBI) | Number of Patients Surviving Overall | 21 Participants |
| Primary - Reg B (TBI Alone) | Number of Patients Surviving Overall | 3 Participants |
| Adjunct | Number of Patients Surviving Overall | 9 Participants |
Number of Patients With Chronic Extensive GVHD
Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. Patients were evaluated as described in the National Institutes of Health (NIH) consensus project guidelines.
Time frame: 1 Year post-transplant
Population: One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary - Reg A (Flu/TBI) | Number of Patients With Chronic Extensive GVHD | 8 Participants |
| Primary - Reg B (TBI Alone) | Number of Patients With Chronic Extensive GVHD | 1 Participants |
| Adjunct | Number of Patients With Chronic Extensive GVHD | 5 Participants |
Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD)
Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
Time frame: 100 days post-transplant
Population: One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary - Reg A (Flu/TBI) | Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD) | 15 Participants |
| Primary - Reg B (TBI Alone) | Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD) | 2 Participants |
| Adjunct | Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD) | 6 Participants |
Number of Patients With Recurrent or Progressive Malignancy
CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL, MDS \>5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease. CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
Time frame: 1 Year post-transplant
Population: One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary - Reg A (Flu/TBI) | Number of Patients With Recurrent or Progressive Malignancy | 7 Participants |
| Primary - Reg B (TBI Alone) | Number of Patients With Recurrent or Progressive Malignancy | 4 Participants |
| Adjunct | Number of Patients With Recurrent or Progressive Malignancy | 3 Participants |