Tulane Clinical Research Protocols
BMT 98-1

Primary Endpoints
Treatment
Eligibility Criteria
Pre-Study Requirements

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BMT 98-1: Bone marrow transplantation for high-risk leukemias.

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Primary Endpoints

1. To determine the recovery time of granulocytes and platelets following allogeneic and autologous transplants using G-CSF primed bone marrow harvests.
2. To compare the recovery time of the study group to unprimed marrow or mobilized peripheral blood progenitors.
3. Observe and monitor toxicities in donors and recipients.
4. Analyze hematopoietic progenitor content of primed marrow
5. Compare recovery times from primed allogeneic vs. autologous transplants.
6. Compare costs of primed bone marrow harvest to PBSC collection.

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Treatment

TREATMENT	D-9	D-8	D-7	D-6	D-5	D-4	D-3	D-2	D-1	0
Busulfan 1 mg/kg po q 6 hours x 16 doses		X	X	X	X
Etoposide * 40 mg/kg IV over 1 hr (age 0-60 yrs) * 60 mg/kg IV over 4 hr (age < 18 if AML)						X
Cyclophosphamide 60 mg/kg IV over 1 hr x 2 days							X	X
Dilantine 5 mg/kg po / IV q6h x 4, then qd until 48hr post Busulfan		X	X	X	X	X	X
IT methotrexate 10 mg/m2 (max 12mg): ALL pts. only	X
Radiation therapy: testicular (ALL pts. only)	X	X	X
Transplant										X

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Eligibility Criteria

1. ALL in CR1 elegible for allogeneic transplant if:
   a. age < 1 year or t(9,22) or t(4,11)
   b. Two of the following criteria are met:
   i. wbc > 10,000 (age < 18), wbc > 30,000 (age => 18)
   ii. time to initial remission > 4 weeks
   iii. other high-risk cytogenetic abnormality
2. ALL CR2
   a. Adults (=> 18-60 yo). Allogeneic if HLA-matched related donor, autologous if not.
   b. Children (age 0-<18 years) with relapse on therapy or 2 24 months from diagnosis or T cell or B cell disease
3. ALL CR3 age 0-50 eligible for allogeneic transplant if suitable donor. If no donor, elegible for autologous transplant if autologous harvest from CR available.
4. AML: allogeneic if HLA-matched donor available or autologous if remission-primed and harvested marrow is available.
   a. age 18 to 60 years with > CR1
   b. age 0 < 18 years with => CR1 (except M3 CR1)
5. CML: age 0-55 years: > 1st CP if HLA-matched related donor available.
6. MDS-RAEB or RAEBiT, age 0-55 years: if HLA-matched donor available.
7. Performance status 0-1
8. No major organ dysfunction.
9. No active uncontrolled infections.
10. Informed consent signed by patient and donor (if allogeneic transplant)

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Pre-Study Requirements

1. H&P, wt/ht, BSA, performance status, pre-transplant consultation per unit policy; dental, nutrition, psychosocial, financial screening and clearance, pulmonary function studies including DLCO and ABG, lumbar puncture to evaluate for CNS leukemia.
2. Imaging studies: PA/LAT CXR, EKG, ECHO, or MUGA with ejection fraction.
3. Bone marrow aspirate for cytology, cytochemistry, cytogenetics (identify subtypes of specific disorders according to FAB classification)
4. Labs: ABO, Rh typing, HLA typing, RBC cross match between patient, marrow donor, and all cell support donors, mixed lymphocyte culture and leukocyte cross match between recipient and marrow donors, hepatitis A, B, & C antigens & Ab, HIV Ab, CMV, EBV, herpes simplex and herpes zoster titers in recipient & donors, genetic marker analysis of donor and recipient (cytogenetic studies, red cell enzymes, red cell antigens, RFLP of DNA, etc.), cbc, platelet, diff, retic., Ca, K, Cl, CO2, Mg, PO4, uric acid, alk.phos., ALT, AST, bilirubin, albumin, total protein, BUN, creatinine, glucose, LDH, immunoglobulins, PT, PTT, creatinine clearance (24 hr urine).

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