Donor Stem Cell Transplant or Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia in Remission

NCT01020734 | Completed Phase 2

• 2 other identifiers: CDR0000659891AMC-UUCM-2009-0579
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Giving chemotherapy before a donor bone marrow or peripheral blood stem cell 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor stem cell transplant or bone marrow transplant works in treating patients with acute myeloid leukemia in remission.

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with del(5q); adult acute myeloid leukemia with t(16;16)(p13;q22); recurrent adult acute myeloid leukemia; adult acute myeloid leukemia in remission; childhood acute myeloid leukemia in remission; recurrent childhood acute myeloid leukemia; adult acute minimally differentiated myeloid leukemia (M0); childhood acute minimally differentiated myeloid leukemia (M0); adult acute myeloblastic leukemia without maturation (M1); childhood acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); childhood acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); childhood acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); childhood acute monoblastic leukemia (M5a); childhood acute monocytic leukemia (M5b); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); childhood acute erythroleukemia (M6); adult acute megakaryoblastic leukemia (M7); childhood acute megakaryocytic leukemia (M7)

Outcome Measures

Primary Outcomes (1)

• Efficacy of the treatment measured in terms of frequency of relapse and duration of remission

  duration of CR, leukemia recurrence

  up to 2 years after transplantation

Secondary Outcomes (4)

• Engraftment

  up to 35 days after transplantation

• Acute and chronic graft-versus-host disease

  up to 100 days for acute GVHD and up to 2 years for chronic GVHD

• Treatment-related mortality

  up to 2 years after transplantation

• Leukemia-free survival and overall survival

  up to 2 years after transplantation

Study Arms (1)

transplantation

EXPERIMENTAL

perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes

Biological: anti-thymocyte globulin; Drug: busulfan; Drug: cyclophosphamide; Drug: cyclosporine; Drug: fludarabine phosphate; Drug: methotrexate; Procedure: allogeneic hematopoietic stem cell transplantation

Interventions

anti-thymocyte globulin BIOLOGICAL

transplantation

busulfan DRUG

transplantation

cyclophosphamide DRUG

transplantation

cyclosporine DRUG

transplantation

fludarabine phosphate DRUG

transplantation

methotrexate DRUG

transplantation

allogeneic hematopoietic stem cell transplantation PROCEDURE

transplantation

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria: * Achieved complete response (CR1) after induction chemotherapy * Recurrent AML that went into second CR (CR2) after salvage chemotherapy, except those who have undergone prior allogeneic HSCT * No acute promyelocytic leukemia or acute myeloid leukemia with chromosomal changes t(8;21), inv 16, or t(15;17) * Must have a donor available meeting one of the following criteria: * HLA-matched sibling of 65 years or younger * 6/6 HLA-matched unrelated donor (younger than 55 years) for antigen A, B, and DR * HLA-mismatched family member (offspring, parents, haploidentical sibling) PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Bilirubin \< 2.0 mg/dL * AST \< 3 times the upper limit of normal * Creatinine \< 2.0 mg/dL * Ejection fraction \> 40% on MUGA scan * Negative pregnancy test PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (2)

Inje University - Haeundae Paik Hospital

Busan, 612-030, South Korea

Location

Asan Medical Center - University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute

Interventions

Antilymphocyte Serum; Busulfan; Cyclophosphamide; Cyclosporine; fludarabine phosphate; Methotrexate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; 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; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kyoo H. Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: May 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

KR (2)