Adult Acute Erythroid LeukemiaPhase 2NCT00101140
Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
A Phase 2 study testing anti-thymocyte globulin, fludarabine phosphate and thiotepa in people with Adult Acute Erythroid Leukemia and Adult Acute Monoblastic and Acute Monocytic Leukemia, run by Eastern Cooperative Oncology Group.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Adult Acute Erythroid Leukemia, Adult Acute Monoblastic and Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia
- What is being tested?
- anti-thymocyte globulin, fludarabine phosphate and thiotepa
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
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
About this study
Official title: Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission
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.
Read the detailed 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.
- Conditions
- Adult Acute Erythroid Leukemia, Adult Acute Monoblastic and Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia
- Being tested
- anti-thymocyte globulin, fludarabine phosphate, thiotepa, biological therapy, bone marrow ablation with stem cell support
- Keywords
- adult erythroleukemia (M6a), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myelomonocytic leukemia (M4)
- Medical subject headings
- Leukemia, Erythroblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Leukemia, Megakaryoblastic, Acute, Congenital Abnormalities, Leukemia, Myelomonocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinDrug
thiotepaDrug
biological therapyProcedure or surgery
bone marrow ablation with stem cell supportProcedure or surgery
chemotherapyProcedure or surgery
non-specific immune-modulator therapyProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Erythroid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Mark R. Litzow, MD, Study chair, Mayo ClinicJacob M. Rowe, MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101140
- Sponsor's protocol ID
- CDR0000405838
- Other IDs
- ECOG-E1903
- Status last verified
- Oct 2017
- First submitted
- 7 Jan 2005
- Last updated
- 19 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission
- ClinicalTrials.gov ID
- NCT00101140
- Acronym / sponsor ID
- CDR0000405838
- Conditions
- Adult Acute Erythroid Leukemia, Adult Acute Monoblastic and Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia
- Keywords
- adult erythroleukemia (M6a), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 10 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-thymocyte globulin | Drug | – |
| fludarabine phosphate | Drug | – |
| thiotepa | Drug | – |
| biological therapy | Procedure or surgery | – |
| bone marrow ablation with stem cell support | Procedure or surgery | – |
| chemotherapy | Procedure or surgery | – |
| non-specific immune-modulator therapy | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark R. Litzow, MD study chair
Mayo Clinic
Jacob M. Rowe, MD
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-thymocyte globulin, fludarabine phosphate and thiotepa in people with Adult Acute Erythroid Leukemia and Adult Acute Monoblastic and Acute Monocytic Leukemia, run by Eastern Cooperative Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.