Bone Marrow Transplant in Treating Patients With Hematologic Cancers

NCT00005797 | Completed Phase 2

• 3 other identifiers: MCC-11281MCC-IRB-4188NCI-G00-1759
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with hematologic cancers.

Conditions

Chronic Myeloproliferative Disorders; Leukemia; Multiple Myeloma and Malignant Plasma Cell Neoplasms; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Keywords

refractory multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; refractory chronic lymphocytic leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; polycythemia vera; primary myelofibrosis; essential thrombocythemia; refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; previously treated myelodysplastic syndromes; refractory cytopenia with multilineage dysplasia; chronic eosinophilic leukemia; chronic neutrophilic leukemia; atypical chronic myeloid leukemia, BCR-ABL1 negative; myelodysplastic/myeloproliferative neoplasm, unclassifiable; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12); childhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival

  Relapse free survival 5 post transplant deteremiend by the Kaplan-Meier product-limit method.

  5 years post transplant

Study Arms (2)

BuCy2

OTHER

Busulfan \& Cyclophosphamide

Drug: busulfan; Drug: Cyclophosphamide

VP16/TBI

OTHER

Fractionated Total Body Irradiation + VP-16

Drug: VP-16; Radiation: Fractionated Total Body Irradiation (FTBI)

Interventions

busulfan DRUG

administered on Day -7 through Day -4. The total dose is 12.8 mg/kg

Also known as: Busulfex®

BuCy2

Cyclophosphamide DRUG

administered at a dose of 60 mg/kg on each of two successive days (Days -3 and -2)

BuCy2

VP-16 DRUG

administered as a single infusion on Day -3. The dose is 60 mg/kg and is calculated on actual body weight unless the patient's weight is \>/= 150% of IBW, in which case adjusted body weight will be used.

Also known as: Etoposide (VP-16; Vepesid(R) brand only)

VP16/TBI

Fractionated Total Body Irradiation (FTBI) RADIATION

FTBI is performed on day -7 through day -4. The total dose of radiation is 1,320 cGy.

VP16/TBI

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of: * Acute myelogenous leukemia * Complete remission (CR) 1 - ALL except good cytogenetics defined as \[(inv16, t(8,21), t(15,17)\] * CR2 * Induction failures * Relapsed OR * Acute lymphocytic leukemia (ALL) * CR1 - high risk defined as overt CNS involvement, 1 or more risk factors (age 30 and over, WBC at least 20,000/mm\^3, at least 4 weeks to CR1, myeloid phenotype) * CR2 * Induction failures * Relapsed OR * Chronic myelogenous leukemia * Chronic phase (CP) 1 * Accelerated phase (AP)/CP2 OR * Chronic lymphocytic leukemia * At diagnosis - RAI stage III/IV or Binet C * Must undergo 1 induction regimen * Relapsed - any stage * Must have received no more than 3 regimens for diagnosis OR * Multiple myeloma * At diagnosis - stage II/III (primary refractory or sensitive) * Relapsed no more than 2 times - sensitive disease * Plasma cell leukemia OR * Myelodysplasia * All subtypes eligible OR * Myeloproliferative disorders * Poor response to medical therapy OR * Cytogenetic abnormalities * Must have a related donor who is genotypic 6 out of 6 HLA A, B, and DR match * Molecular DR matching required PATIENT CHARACTERISTICS: Age: * 15 to 55 Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 3 times upper limit of normal * PT/PTT normal Renal: * Creatinine no greater than 2.0 mg/dL * Creatinine clearance at least 60 mL/min Cardiovascular: * LVEF at least 45% by MUGA scan or echocardiography * No myocardial infarction within the past 6 months * No arrhythmias controlled by therapy Pulmonary: * FEV\_1 at least 50% predicted * DLCO at least 50% predicted Other: * Not pregnant or nursing * Negative pregnancy test * No diabetes mellitus or thyroid disease that is not medically controlled * No psychosocial disorder that would preclude study compliance * No active serious infections * HIV negative * Donor must be HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Leukemia; Multiple Myeloma; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Polycythemia Vera; Primary Myelofibrosis; Thrombocythemia, Essential; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic; Pdgfra-Associated Chronic Eosinophilic Leukemia; Leukemia, Neutrophilic, Chronic; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Congenital Abnormalities

Interventions

Busulfan; Cyclophosphamide; Etoposide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Anemia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Teresa Field, MD, PhD

  H. Lee Moffitt Cancer Center and Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: March 1, 1993
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 10, 2020

Record last verified: 2012-10

Locations

US (1)