Reduced Toxicity and Reduced Intensity conditioning chemotherapy using Fludarabine and Treosulfan in allogenic bone marrow transplantatio

Phase 2

• Conditions: Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue

• Registration Number: CTRI/2020/09/027731
• Lead Sponsor: Tata Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients with Advanced or high-risk Hematological Cancers:

oAcute 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).

oHigh risk Myelodysplastic Syndrome [MDS with adverse cytogenetics defined by IPSS (and periodically updated), MDS with excess blasts, MDS with Multilineage dysplasia]

oRelapsed or Refractory Lymphomas, which are chemo-sensitive [defined as a complete or partial response to salvage systemic therapies administered pre- transplantation]

oRare high-risk histologies like Blastic Plasmacytoid Dendritic Cell Neoplasm, etc. can be considered if in complete remission / response

oHigh risk Acute Lymphoblastic Leukemia in remission and not eligible for myeloablative conditioning therapies

oCML 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 < 2.5 mg/dL and aspartate and alanine aminotransferases and alkaline phosphatase <5 x the upper limit of normal;

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

1.Acute Leukemias not in complete morphological remission, and relapsed refractory Lymphomas with less than partial response.

2.Autologous hematopoietic transplant < 3 months prior to enrolment

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified