Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue
Conditions
Interventions
Intervention1: Reduced toxicity, reduced intensity conditioning drug regimen
: Fludarabine, 30mg/sq.m, days -6 to -2
Treosulfan, 10g/sq.m, days -6 to -4
Control Intervention1: NA: NA
Sponsors
Tata Medical Center
Unrestricted research grant
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with Advanced or high-risk Hematological Cancers: o Acute Myeloid Leukemia (AML): intermediate and high risk cytogenetics and molecular markers [as defined by ELNet and periodically updated, inclusive but not restricted to Complex karyotype, monosomy 7, Philadelphia positive, any of inv(3) or t(3;3), t(6;9), +8 alone, MLL gene rearranged; secondary AML, FAB M6/M7 leukemia]; in CR1 and AML with greater than one induction cycle required for remission(CR2). o High risk Myelodysplastic Syndrome [MDS with adverse cytogenetics defined by IPSS (and periodically updated), MDS with excess blasts, MDS with Multilineage dysplasia] o Relapsed or Refractory Lymphomas, which are chemo-sensitive [defined as a complete or partial response to salvage systemic therapies administered pre- transplantation] o Rare high-risk histologies like Blastic Plasmacytoid Dendritic Cell Neoplasm, etc. can be considered if in complete remission / response o High risk Acute Lymphoblastic Leukemia in remission and not eligible for myeloablative conditioning therapies o CML in Myeloid blast crisis and in CR or chronic phase, pre-transplant 3. HLA matched, haplo-identical and partially mismatched, related or unrelated donor available 4. Patients must have received antineoplastic therapy within 3 months of consent date (measured from the start date of antineoplastic therapy). 5. Left ventricular ejection fraction >= 40%; 6. Pulmonary function: DLCO (carbon monoxide corrected diffusion lung capacity), FEV1 (forced expiratory volume in the first second), or FVC (functional vital capacity) 50% of predicted; 7. Liver function: total bilirubin 8. Renal function: Serum creatinine within the normal range for age or measured creatinine clearance or calculated glomerular filtration rate 40 mL/min/1.73 sq.m 9. ECOG performance score of 0-2 10. HCT Co-morbidity Index: Low and Intermediate risk score (0-2) 11. Study treatment both planned and able to start within 4-6 weeks of registration 12. Tissue sample available
Exclusion criteria
Exclusion criteria: 1. Acute Leukemias not in complete morphological remission, and relapsed refractory Lymphomas with less than partial response. 2. Autologous hematopoietic transplant 3. Pregnancy or breast feeding 4. Evidence of HIV infection or known HIV positive serology 5. Current uncontrolled bacterial, viral or fungal infection: currently taking medications, or with evidence of progression of clinical symptoms or radiologic findings) 6. Patients with history of primary idiopathic myelofibrosis 7. Contraindications to any of the drug used 8. Serious psychiatric conditions that might limit the ability of the patient to comply with the protocol 9. Prior allogeneic hematopoietic cell transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the 100 day regimen related toxicity. Timepoint: Incidence of Grade-III/IV Mucositis (Oral and Gut) Incidence of other grade III/IV non-hematological adverse events [CTCAE V4.0] Requirement and duration of TPN Documented and clinically suspected Infection rate, and requirement and duration of antimicrobial chemotherapy. Length of Hospital stay | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 yr GVHD relapse Free Survival (GRFS) 1 yr Overall Survival 1 yr relapse rate 1 yr transplant related mortality Timepoint: 1 year post transplant | — |
Countries
India
Contacts
Public ContactVivek Radhakrishnan
Tata Medical Center
Outcome results
None listed