Status:
TERMINATED
Study of Low Intensity Conditioning and Immunotherapy for High-Risk Cancers of the Blood
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Leukemia
Lymphoma, Low-Grade
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell transplant.
Detailed Description
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell transplant (SCT)...
Eligibility Criteria
Inclusion
- Patient
- One of the following hematological malignancies:
- Chronic myelogenous leukemia
- Accelerated phase
- Blast phase
- Acute myelogenous leukemia
- First or greater complete remission if high risk features: abnormalities of chromosomes with known poor prognosis 5 or 7.
- Relapsed or refractory patients with ≤ 30% blasts
- Aged 55 years or older in any disease state beyond first remission if blast percentage is \< 30%.
- Acute lymphoblastic leukemia
- First complete remission if high risk features: t(4;11)
- Second complete remission if relapse occurs within the first 12 months of therapy
- Third or greater complete remission
- Relapsed or refractory patients with ≤ 30% blasts
- Aged 55 years or old in second in any disease state beyond first remission if blast percentage is \< 30%.
- Myelodyplastic syndromes
- RAEB or RAEB-t patients, 55 years of age or older
- Any hematologic malignancy relapsed following autologous or matched related donor allogeneic stem cell transplant provided at least 90 days has elapsed from most recent transplant
- Non-Hodgkin's Lymphoma
- 55 years or older, who have failed anthracycline containing regimen and do not have any tumor larger than 5 cm in diameter.
- Patients with rapidly progressive disease are ineligible.
- Multiple myeloma patients, any age, who meet at least one of the following criteria:
- disease refractory to conventional chemotherapy such as VAD, pulse decadron, or alkylating agents, OR
- chromosomal abnormality by cytogenetics or FISH probe.
- Chronic lymphoblastic leukemia patients
- Any age
- Advanced disease (Rai stage 3 or 4)
- Relapsed following/refractory to alkylating agents or nucleoside analog therapy
- NOTE: Patients with bulky disease (lymphadenopathy \> 5 cm) or progressive disease NOT eligible.
- Mantle cell lymphoma
- Any age
- Disease stage 3 or 4
- Lymphadenopathy must not exceed 5 cm in any dimension
- Any eligible disease category, any age, if ineligible for myeloablative conditioning because of organ dysfunction or advanced age (55 years or older). Minimum organ function for patients entered on this protocol defined as:
- Cardiac: Ejection fraction at least 30%.
- Renal: Creatinine \<1.5 times normal for age.
- Pulmonary: FEV1 and FVC \>60%.
- Hepatic: Total bilirubin \<2.0 and AST/ALT \<3 X institutional normal for age.
- Performance (adults): Karnofsky score must be at least 60; for pts. under 16, Lansky score must be at least 60.
- Low grade lymphoma (small lymphocytic, follicular small cleaved cell, or follicular mixed small cleaved and large cell) must meet the following criteria:
- any age
- relapsed or refractory disease provided the disease is NOT rapidly progressive
- no lymphoma mass or lymph node exceeds 5 cm in greatest dimension
- Age: no age restriction
- Availability of a 6/6 HLA A, B, and DR identical relative who is willing and able to donate allogeneic stem cells
- No active infection
- Serum creatinine less than 1.5 times normal for age
- Serum bilirubin less than 1.5 times normal for age
- Not pregnant.
- Patient
Exclusion
- HIV positive patients not eligible
- Pregnant
- Donor Inclusion Criteria:
- 6/6 HLA match for HLA-A, B, and DR
- Age 3-70 years, good general health
- No contraindication to G-CSF stimulation
- No contraindication to leukapheresis of peripheral blood stem cells
- Good general health
- Donor
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00143884
Start Date
March 1 2000
Last Update
April 23 2007
Active Locations (1)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109