A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-05-31

Study Completion Date

2000-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the effects of the combination of all-trans retinoic acid in combination with one of two schedules of Bryostatin 1 in patients with myelodysplasia and acute myelogenous leukemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia

NCT01174888

Acute Myeloid Leukemia Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome +8 more

COMPLETED PHASE1

Study of TCP-ATRA for Adult Patients With AML and MDS

NCT02273102

Acute Myelogenous Leukemia Myelodysplastic Syndromes Leukemia

COMPLETED PHASE1

Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT00151242

Acute Myeloid Leukemia

COMPLETED PHASE2/PHASE3

All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT00151255

Acute Myeloid Leukemia

COMPLETED PHASE3

All-trans Retinoic Acid, and Arsenic +/- Idarubicin

NCT00413166

Acute Promyelocytic Leukemia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All patients receive all-trans retinoic acid at a dose of 150 mg/m2/day and patients are randomized to one of two schedules of Bryostatin 1.

Arm 1: Bryostatin 1 is administered at a dose of 60 mcg/m2 as a 30 minute intravenous (IV) infusion on days 8 and 22.

Arm 2: Bryostatin 1 is administered at a dose of 40 mcg/m2 as a 72 hour IV infusion starting on days 8 and 22.

Patients are assessed for response on day +50 with a bone marrow examination and patients with either a clinical response or stable disease receive further therapy.

Bryostatin 1 pharmacokinetic samples are to be drawn on days 1, 8 and 50 of each cycle.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myelogenous Leukemia Myelodysplastic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

All-trans retinoic acid

Intervention Type DRUG

Bryostatin 1

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with AML who have failed induction chemotherapy.
* Patients with secondary AML
* Patients with AML over age 60 who are deemed not to be a candidate for chemotherapy.
* Patients with any subtype of MDS.
* Age 18 or greater.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Satisfactory liver and kidney function.
* Greater than 4 weeks from prior chemotherapy or radiation therapy.