Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine disease-free survival, overall survival, time to progression, regimen-related toxicity and/or treatment-related mortality in patients with hematologic malignancies treated with non-myeloablative chemotherapy followed by allogeneic stem cell transplant.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Methotrexate

Criteria

Inclusion Criteria:

• Age: 18-75 years

• Diseases

1. Chronic myelogenous leukemia (CML)

• First chronic phase or later

• Accelerated phase

2. Acute myelogenous or lymphoblastic leukemia (AML or ALL)

• Second or subsequent remission

• Patients who have failed an autologous PBSC transplant

• First remission with poor risk features, including, but not limited to: For AML- complex chromosome karyotype, abnormalities of chromosome 5 or 7, 12p-, 13+, 8+, t(9;22), t(11;23) For ALL- t(9;22), t(4;11), t(1;19), myeloid antigen coexpression

3. Myelodysplastic syndrome (MDS)

4. Multiple myeloma - high risk myeloma (poor responders, relapse after autologous PBSCT, chromosome 13 abnormalities)

5. Hodgkin's disease

• Primary refractory disease

• Relapsed disease (first relapse or later)

• Patients who have failed an autologous PBSC transplant

6. Non-Hodgkin's lymphoma Low grade (by Working Formulation)

• Relapsed, progressive disease after initial chemotherapy

• Primary refractory disease or failure to respond (>PR) to initial chemotherapy

• Patients who have failed an autologous PBSC transplant Intermediate grade (by Working Formulation)

• Relapsed disease

• Primary refractory disease or failure to respond (>PR) to initial chemo

• Mantle cell lymphoma

• Patients who have failed an autologous PBSC transplant

7. Chronic lymphocytic leukemia (CLL)

• Patients newly diagnosed with poor prognostic factors, including CD38 expression, Chromosome 11 or 17 abn

• T-CLL/PLL

• Relapsed or progressive disease, or refractory after Fludarabine

• Patients who have failed an autologous PBSC transplant

• Donor Availability: Six of six matched HLA A, B and DR identical sibling (or parent or child) or 5/6 related donor with single mismatch at Class I antigen (A or B)

• Karnofsky performance status of >70%

• Serum bilirubin <2x upper limit of normal; transaminases <3x normal (unless due to disease)

• 24 hr urine creatinine clearance of >40 ml/min.

• DLCO >50% predicted

• Left ventricular ejection fraction >35%

• No active infection

• Non-pregnant female

• Signed informed consent

• No major organ dysfunction or psychological problems that preclude compliance and completion of the clinical trial.

Exclusion Criteria

• Major organ dysfunction

• Pregnant or lactating female

• Active infection

• Psychological problems that preclude compliance and completion of the clinical trial

• Any other condition, that in the judgement of the investigator, affects participant safety or overall participation