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

Adult Acute Myeloid Leukemia Clinical Trial

Official title:

Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00101140
• Other study ID #: CDR0000405838
• Secondary ID: ECOG-E1903
• Status: Withdrawn
• Phase: Phase 2
• First received: January 7, 2005
• Last updated: October 18, 2017

Study information

• Verified date: October 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission.

Description:

OBJECTIVES:

Primary

• Determine the safety and antileukemia activity of haploidentical allogeneic peripheral blood stem cell transplantation in patients with high-risk acute myeloid leukemia in first remission.

Secondary

• Determine the early treatment-related mortality (before day 100) of patients treated with this regimen.

• Determine the incidence of acute graft-versus-host disease in patients treated with this regimen.

• Determine the incidence of graft failure in patients treated with this regimen.

• Correlate a mismatch in the expression of the natural killer cell inhibitory receptors CD158a and CD158b with engraftment and disease recurrence in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive a preparative regimen comprising total-body irradiation twice on day -8; fludarabine IV over 30 minutes on days -7 to -3; thiotepa IV over 2 hours twice on day -7; and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo haploidentical allogeneic peripheral blood stem cell transplantation on day 0.

Patients are followed at day 100, at least monthly for 2 years, and then periodically for 3 years.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2.2 years.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

DISEASE CHARACTERISTICS:

• Morphologically confirmed acute myeloid leukemia of 1 of the following subtypes:

• Acute myeloblastic leukemia (M0, M1, M2)

• Acute myelomonocytic leukemia (M4)

• Acute monocytic leukemia (M5)

• Acute erythroleukemia (M6)

• Acute megakaryocytic leukemia (M7)

• Must have 1 of the following karyotypic abnormalities at the time of diagnosis:

• Complex cytogenetic abnormalities (= 3 cytogenetic clones)

• Abnormalities of chromosome 5 [-5 or del(5q)]

• Abnormalities of the long (q) arm of chromosome 3, 9, 11, 20, or 21

• Abnormalities of the short (p) arm of chromosome 17, monosomy 7, t(9;22), or t(6;9) (8)

• In morphologic first complete remission*, as evidenced by all of the following for = 4 weeks before study entry:

• Absolute neutrophil count > 1,000/mm^3

• Platelet count > 100,000/mm^3

• Leukemic blasts not present in the peripheral blood

• Cellularity of bone marrow biopsy > 20% with maturation of all cell lines

• Less than 5% blasts by bone marrow biopsy

• No extramedullary leukemia, such as CNS or soft tissue involvement NOTE: *Reduced hemoglobin concentration or hematocrit has no bearing on remission status

• Haploidentical (3/6 or 4/6 antigen matched [A, B, and DR]) family donor available

PATIENT CHARACTERISTICS:

Age

• 18 to 59

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin = 2.0 mg/dL

• AST < 2 times upper limit of normal

Renal

• Creatinine = 1.5 mg/dL

Cardiovascular

• Ejection fraction > 40% by MUGA or echocardiogram

• None of the following within the past 3 months:

• Myocardial infarction

• Significant congestive heart failure

• Significant cardiac arrhythmia

Pulmonary

• FEV_1 and DLCO > 50% of predicted

Immunologic

• HIV negative

• No active or unresolved infection

• No evidence of invasive fungal infection (e.g., positive blood or deep tissue cultures or stains)

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No organ damage

• No other medical problem that would preclude study participation

• No other currently active tumor that would likely interfere with study treatment or that would likely compromise the patient's morbidity or mortality

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) to accelerate hematopoietic recovery post-transplantation

Chemotherapy

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Related Conditions & MeSH terms

• Adult Acute Erythroid Leukemia
• Adult Acute Monoblastic and Acute Monocytic Leukemia
• Adult Acute Myeloid Leukemia
• Leukemia
• Leukemia, Erythroblastic, Acute
• Leukemia, Monocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• anti-thymocyte globulin

• fludarabine phosphate

• thiotepa

Procedure:
• biological therapy

• bone marrow ablation with stem cell support

• chemotherapy

• non-specific immune-modulator therapy

• peripheral blood stem cell transplantation

• radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)