CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
Anti-Thymocyte Globulin +8 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01168219
NCT01168219Phase 2Completed
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Phase II Study of the Addition of Azacitidine (NSC#102816) to Reduced-Intensity Conditioning Allogeneic Transplantation for Myelodysplasia (MDS) and Older Patients With AML

National Cancer Institute (NCI)·interventional·Posted Jul 23, 2010·Updated Aug 4, 2022

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Anti-Thymocyte Globulin, and 7 other interventions for Acute Myeloid Leukemia and 19 related conditions. Completed, enrolled 68 participants across 17 sites.

Detailed Summary

This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate, and anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in treating patients with high-risk myelodysplastic syndrome and older patients with acute myeloid leukemia. Giving low doses of chemotherapy, such as busulfan and fludarabine phosphate, before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-vs-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving anti-thymocyte globulin before transplant and giving azacitidine, tacrolimus, and methotrexate after the transplant may stop this from happening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With Minimal Differentiation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myelomonocytic Leukemia, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Alkylating Agent-Related Acute Myeloid Leukemia, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Recurrent Adult Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 23, 2010
Enrollment StartJul 15, 2010
Primary CompletionNov 14, 2015
Study CompletionFeb 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.9 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic hematopoietic stem cell transplantation

Anti-Thymocyte Globulinbiological

Given IV

Azacitidinedrug

Given SC or IV

Busulfandrug

Given IV

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Methotrexatedrug

Given IV

Pharmacological Studyother

Correlative studies

Tacrolimusdrug

Given PO or IV