Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia

NCT00630565 | Terminated Phase 2 Results DMC

• 2 other identifiers: MT2006-130607M89052
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy and colony-stimulating factors, such as G-CSF, may increase the number of stem cells in the blood. The stem cells are collected from the patient's blood and stored. Chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. PURPOSE: This clinical trial is studying how well an autologous stem cell transplant works in treating patients with acute myeloid leukemia.

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remission; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(16;16)(p13;q22); childhood acute myeloid leukemia in remission

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Engraftment

  Percentage of Participants with Engraftment measured by myeloid, platelet, and erythroid recovery

  30 Days Post Transplant

Secondary Outcomes (5)

• Percentage of Participants With Disease Response

  2 years Post Transplant

• Treatment Failure

  2 years Post Transplant

• Percent of Patients With Various Late Effects

  2 years Post Transplant

• Disease-free Survival

  2 years Post Transplant

• Percentage of Patients With Adequate Cells Collected

  Pre-Transplant

Study Arms (2)

Bone Marrow Transplant (2-70 Years old)

EXPERIMENTAL

Patients over the age of two will receive a cytoreductive regimen of total-body irradiation and cyclophosphamide (TBI/CY) as well as sargramostim, dexamethasone, etoposide, transplantation (bone marrow transplantation/hematopoietic stem cell transplantation/peripheral blood stem cell transplantation).

Biological: sargramostim; Drug: cyclophosphamide; Drug: dexamethasone; Drug: etoposide; Procedure: bone marrow transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: total-body irradiation

Bone Marrow Transplant (less and 2 years old)

EXPERIMENTAL

Patients under the age of two, and patients who cannot receive total body irradiation (TBI), will receive a cytoreductive regimen of Busulfan and cyclophosphamide (BU/CY) as per the Johns Hopkins University Hospital regimen as well as sargramostim, dexamethasone, etoposide, transplantation (bone marrow transplantation/hematopoietic stem cell transplantation/peripheral blood stem cell transplantation).

Biological: sargramostim; Drug: busulfan; Drug: cyclophosphamide; Drug: dexamethasone; Drug: etoposide; Procedure: hematopoietic stem cell transplantation

Interventions

sargramostim BIOLOGICAL

Given subcutaneously (SC) 10 μg/kg/day from day +3 until apheresis is completed

Also known as: G-CSF

Bone Marrow Transplant (2-70 Years old); Bone Marrow Transplant (less and 2 years old)

busulfan DRUG

4 mg/kg po in 4 divided doses (.8 mg/kg/dose orally every 6 hours) on days -7 through -4.

Also known as: Busulfex

Bone Marrow Transplant (less and 2 years old)

cyclophosphamide DRUG

4 gm/m\^2 x 1 (day 0) and 60 mg/kg intravenous (IV) over 2 hours on days -3 and -2.

Also known as: Cytoxan

Bone Marrow Transplant (2-70 Years old); Bone Marrow Transplant (less and 2 years old)

dexamethasone DRUG

20 mg/m\^2 x 4 doses every 12 hours given intravenously (IV) push before cytoxan on day 0 and then every 12 hours

Also known as: Decadron

Bone Marrow Transplant (2-70 Years old); Bone Marrow Transplant (less and 2 years old)

etoposide DRUG

300 mg/m\^2/day x 2 days (day 0-1) over 3 hours intravenously (IV)

Also known as: VP-16

Bone Marrow Transplant (2-70 Years old); Bone Marrow Transplant (less and 2 years old)

bone marrow transplantation PROCEDURE

Day 0 infusion of bone marrow cells

Also known as: ABMT

Bone Marrow Transplant (2-70 Years old)

hematopoietic stem cell transplantation PROCEDURE

Stem cell infusion (\>48 hours after the last dose of cyclophosphamide)

Also known as: HSCT

Bone Marrow Transplant (less and 2 years old)

peripheral blood stem cell transplantation PROCEDURE

Day 0 infusion of peripheral blood stem cells

Also known as: PBSCT

Bone Marrow Transplant (2-70 Years old)

total-body irradiation RADIATION

165 cGy/dose given twice a day on days -7 through -4.

Also known as: TBI

Bone Marrow Transplant (2-70 Years old)

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children under the age of two are eligible for this protocol, but will not receive total body irradiation. Instead, children under the age of two will receive Busulfan/Cyclophosphamide (Bu/Cy) conditioning as the preparative regimen in order to obviate deleterious effects of radiation at this age. Patients who cannot receive total body irradiation (TBI) (for example those with prior radiation therapy) will also receive the Bu/CY conditioning.
• Acute myeloid leukemia (AML)
• All children and adults less than the age of 70 with AML who have achieved a first or second bone marrow remission are eligible for this protocol. Patients must undergo peripheral blood stem cell collection or marrow harvest while in remission and must not be expected to have better outcomes with allogeneic transplantation.
• Patients with cytogenetic abnormalities suggesting an improved prognosis \[t(8:21), t(15;17) and inv(16)\] will be eligible for transplantation in first remission.
• Allogeneic transplant with an HLA-identical sibling will be recommended for patients \<55 years. If the patient refuses allogeneic transplant, they may still be eligible for this protocol.

You may not qualify if:

• Patients can also be deemed not eligible for transplant because of specific organ toxicity. Specifically, patients with pre-existing compromise to the heart, lungs, kidney, CNS or liver may be excluded:
• Eastern Cooperative Oncology Group (ECOG) Performance status: 0 or 1
• Heart - The patient must be free of symptoms of uncontrolled cardiac disease, and must not have compromised cardiac function detected by ECHO or by gated cardiac blood flow scan (MUGA) LVEF \>45%).
• Kidney - The patient must have a corrected creatinine clearance \>50% of normal.
• Liver - The total serum bilirubin \< 2.5 mg/dL; ALT \<2 x upper limit of normal.
• Lung - Patients must have no significant obstructive airways disease or resting hypoxemia (PO2 \<80), and must have acceptable diffusion capacity (DLCO \> 50% of predicted).
• Central Nervous System (CNS): Patients must be free of active or ongoing ischemic or degenerative CNS disease and no active or resistant CNS leukemia.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities

Interventions

sargramostim; Granulocyte Colony-Stimulating Factor; Busulfan; Cyclophosphamide; Dexamethasone; Calcium Dobesilate; Etoposide; Bone Marrow Transplantation; Hematopoietic Stem Cell Transplantation; Peripheral Blood Stem Cell Transplantation; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; 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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Glucosides; Glycosides; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Stem Cell Transplantation; Cell Transplantation; Radiotherapy; Investigative Techniques

Results Point of Contact

• Title: Dr. Daniel Weisdorf, MD
• Organization: University of Minnesota, Masonic Cancer Center

weisd001@umn.edu

+1 612-624-3101

Study Officials

• Daniel J. Weisdorf, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 7, 2008
• Study Start: July 26, 2006
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: January 29, 2024
• Results First Posted: January 29, 2024

Record last verified: 2024-01

Locations

US (1)