View Clinical Trial (Medical Research Study)
A Pilot Study of Double Cord Blood Stem Cell Transplantation in Patients With Hematologic Malignancies
| City: |
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Detroit |
| State: |
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Michigan |
| Zip Code: |
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48201 |
| Conditions: |
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Leukemia - Lymphoma - Multiple Myeloma and Plasma Cell Neoplasm - Myelodysplastic Syndromes - Precancerous Condition - Secondary Myelofibrosis |
| Purpose: |
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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 patient's immune system from rejecting the donor's stem cells. The donated
stem cells may replace the patient's immune cells and help destroy any remaining cancer or
abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor
can also make an immune response against the body's normal cells. Giving tacrolimus and
mycophenolate mofetil before the transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well umbilical cord blood stem cell transplant
works in treating patients with hematologic cancer or other disease.
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| Study Summary: |
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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
low-dose total body irradiation, in terms of stem cell engraftment at 60 days post
transplantation, in patients with hematologic cancer or other diseases.
- Determine the merits of conducting a larger, comparative study of this regimen.
Secondary
- Determine mortality within 100 days of transplantation in these patients.
OUTLINE: This is a pilot study.
- Reduced-intensity conditioning regimen: Patients receive busulfan IV over 3 hours on
days -9 to -8 and fludarabine phosphate IV on days -7 to -3. Patients then undergo
low-dose total body irradiation on day 0.
- Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV twice daily and
mycophenolate orally or IV three times daily beginning on day -3.
- CNS prophylaxis and/or treatment: Patients with a history of CNS involvement receive
prophylactic cytarabine (Ara-C) intrathecally (IT) prior to transplant. Patients also
undergo lumbar puncture (LP) to test for active CNS disease. Patients with
cerebrospinal fluid positive for leukemia receive Ara-C IT every 2-3 days until a
repeat LP shows no remaining leukemic cells. Three days after the last LP and after one
final dose of Ara-C, patients begin the conditioning regimen.
- Double umbilical cord blood (UCB) donor stem cell transplantation (SCT): Patients
undergo double UCB donor SCT on day 0.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
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| Criteria: |
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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
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| NCT ID: |
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NCT00423826 |
| Primary Contact: |
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Study Chair
Voravit Ratanatharathorn, MD
Barbara Ann Karmanos Cancer Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Detroit, Michigan 48201
United States
Voravit Ratanatharathorn, MD
Phone: 313-576-8755
Email: ratanath@karmanos.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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