Status:
NO_LONGER_AVAILABLE
Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Up to 69 years
Brief Summary
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells. It also stops the pat...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of double umbilical cord blood stem cell transplantation using a conditioning regimen comprising lower doses of busulfan and fludarabine phosphate and lo...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Acute myeloid leukemia meeting the following criteria:
- M0-M7 histologic subtypes by French-American-British classification
- Previously treated disease
- Meets 1 of the following criteria:
- Persistent disease as evidenced by 5-30% persistent blasts in bone marrow after induction or salvage therapy
- In second or subsequent complete remission (CR)
- In first CR with 1 of the following high-risk features:
- Philadelphia chromosome present
- Noncore-binding factor type of chromosomal abnormalities
- Myelodysplastic syndromes with 1 of the following International Prognostic Scoring System (IPSS) scores:
- Intermediate-1
- Intermediate-2
- High-risk score with transfusion dependence
- Chronic myelogenous leukemia meeting 1 of the following criteria:
- In accelerated or blastic phase
- Failed prior imatinib mesylate therapy
- Acute lymphoblastic leukemia meeting 1 of the following criteria:
- In first CR with any of the following high-risk features:
- Philadelphia chromosome present
- Translocation t(4;11) present
- WBC \> 30,000/mm³ (adult patients)
- More than 4 weeks from initiation of treatment was required to achieve CR (adult patients)
- DNA index of near haploid (N=23 chromosomes) (pediatric patients)
- In second or subsequent CR
- Persistent disease as evidenced by 5-20% persistent blasts in bone marrow after induction or salvage therapy
- Hodgkin's or non-Hodgkin's lymphoma meeting the following criteria:
- Recurrent or refractory disease
- Tumor ≤ 5 cm in diameter
- Myeloma or plasma cell neoplasm meeting 1 of the following staging criteria:
- Stage III at presentation
- Stage I-II at presentation
- Not responding OR progressed after first-line therapy
- Chronic lymphocytic leukemia or Waldenstrom's macroglobulinemia with refractory or progressive disease after first-line therapy
- No 5-6/6 HLA-matched related or 7-8/8 HLA-matched unrelated marrow or peripheral blood stem cell donor available
- No single 4-6/6 HLA-A, -B, or -DRB1-matched umbilical cord blood unit ≥ 3.5 x 10\^7 nucleated cells/kg available
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky or Lansky PS 70-100%
- Not pregnant
- Fertile patients must use effective contraception prior to and during study participation
- HIV negative
- Bilirubin \< 3.0 mg/dL
- AST and ALT ≤ 3 times upper limit of normal
- Creatinine \< 2.0 mg/dL OR creatinine clearance \> 50 mL/min
- Cardiac ejection fraction \> 50% by echocardiogram OR shortening fraction \> 27%
- No uncontrolled symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- FEV\_1 \> 50% of normal
- Forced vital capacity \> 50% of normal
- DLCO normal
- Oxygen saturation \> 92% on room air (for patients \< 5 years of age)
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to busulfan and fludarabine phosphate
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior and no concurrent surgery
- At least 4 weeks since prior and no other concurrent investigational or commercial agents or therapies for the malignancy, including chemotherapy, biologic therapy, or radiotherapy
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
EXPANDED_ACCESS
End Date :
January 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00423826
Start Date
January 1 2007
End Date
January 1 2015
Last Update
February 29 2016
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379