Acute Myelogenous Leukemia, Lymphoid Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia, Myeloproliferative Disorder, Anemia, Aplastic, Myelodysplastic Syndromes
Conditions
Keywords
Relapsed or refractory acute myelogenous or lymphoid leukemia., Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis., Chronic myelogenous leukemia in chronic phase, Chronic myelogenous leukemia in accelerated phase or blast-crisis, Recurrent or refractory malignant lymphoma or Hodgkin's disease., Chronic lymphocytic leukemia, relapsed or with poor prognostic features., Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features., Severe aplastic anemia after failure of immunosuppressive therapy., Myelodysplastic syndromes (including PNH), Multiple myeloma at high risk for disease recurrence.
Brief summary
Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation. 3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
Interventions
DRUGFludarabine
Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.
DRUGMelphalan
Melphalan 140 mg/m2 IV on day -2.
DRUGStem cells
Stem cell infusion on day 0.
DRUGCampath
Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
No
Inclusion criteria
* Zubrod performance status 2 (See Appendix B). * Life expectancy is not severely limited by concomitant illness. * Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol. * Serum creatinine \<1.5 mg/dL or Creatinine Clearance \>50 ml/min . * Serum bilirubin 2.0 mg/dl, SGPT \<3 x upper limit of normal * No evidence of chronic active hepatitis or cirrhosis. * HIV-negative * Patient is not pregnant * Patient or guardian able to sign informed consent.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Disease-free Survival | Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years | All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Overall Survival | Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years | All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T-cell Depleted Allogeneic Stem Cell Transplantation All patients were administered the following drugs;
1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
2. Melphalan 140mg/m2 IV on day -2
3. Stem cell infusion on day 0
4. Campath 20mg IV on day -7,-6,-5,-4, and -3 | 204 |
| Total | 204 |
Baseline characteristics
| Characteristic | T-cell Depleted Allogeneic Stem Cell Transplantation |
|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 204 |
| serious Total, serious adverse events | 69 / 204 |
Outcome results
Primary
Median Disease-free Survival
All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3
Time frame: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| T-cell Depleted Allogeneic Stem Cell Transplantation | Median Disease-free Survival | 333 Days |
Secondary
Median Overall Survival
All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3
Time frame: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| T-cell Depleted Allogeneic Stem Cell Transplantation | Median Overall Survival | 547 Days |