Status:
COMPLETED
Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 maligna...
Detailed Description
Allogeneic bone marrow transplantation (BMT) became feasible in the 1960s after elucidation of the Human Leukocyte Antigen (HLA) complex. Since then, the therapy has evolved into an effective treatmen...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age: 18-75 years
- Diseases
- Chronic myelogenous leukemia (CML)
- First chronic phase or later
- Accelerated phase
- 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
- Myelodysplastic syndrome (MDS)
- Multiple myeloma - high risk myeloma (poor responders, relapse after autologous PBSCT, chromosome 13 abnormalities)
- Hodgkin's disease
- Primary refractory disease
- Relapsed disease (first relapse or later)
- Patients who have failed an autologous PBSC transplant
- 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
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00741455
Start Date
June 1 2004
End Date
May 1 2020
Last Update
November 23 2020
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756