Houston, Texas 77030

  • Myelodysplastic Syndromes

Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.


Study summary:

OBJECTIVES: I. Determine the toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy. II. Determine the engraftment kinetics and degree of chimerism achievable. OUTLINE: The trial will have 2 patient groups. Patients not in remission are assigned to group 1, while patients in remission are assigned to group 2. Then, groups are divided into 2 treatment arms. Patients failing fludarabine therapy receive cytarabine (Ara-C) IV over 2 hours on days -7, -6, -5, -4 and -3. Beginning 4 hours before the first dose of Ara-C, patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) by continuous infusion for 5 days. Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after the beginning of the fludarabine infusion and continues for 4 hours. Idarubicin IV is given on days -6, -5 and -4. Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection. Cells are infused on day 0. For GVHD prophylaxis, all patients receive cyclosporine via continuous IV infusion. Oral cyclosporine is administered once patients tolerate oral feeding and continued for 6 months postinfusion. Then, the dose of cyclosporine is tapered 10% weekly until discontinued. Methylprednisolone begins 5 days after infusion and is gradually tapered. PROJECTED ACCRUAL: A maximum of 15 patients per arm are likely to be entered in 24 to 36 months.


Criteria:

DISEASE CHARACTERISTICS: Acute leukemia with poor risk cytogenetic features (-5,-7, +8) in first complete remission Poor risk myelodysplasia Refractory anemia with excess blasts (RAEB) RAEB in transformation (RAEB-T) Chronic myelomonocytic leukemia (CMML) Chronic myelogenous leukemia (CML) in late chronic phase Acute leukemia with greater than first complete remission or transformed CML or CMML PATIENT CHARACTERISTICS: Age: 55 to 65 65 to 70 (at the discretion of study chairperson on basis of performance status) 55 and under (if declined for conventional high dose chemotherapy due to concurrent medical conditions (i.e. ejection fraction less than 50, FEV1, FVC, or DLCO less than 50%, abnormal LFTs) Performance status: Zubrod less than 2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal: Serum creatinine less than 2 mg/dL Cardiovascular: Ejection fraction greater than 40% per MUGA scan Pulmonary: Not specified Other: No active uncontrolled infection HLA compatible donor capable of donating stem cells via apheresis PRIOR CONCURRENT THERAPY: Not specified


Study is Available At:


Original ID:

DM94-078


NCT ID:

NCT00002833


Secondary ID:

P30CA016672


Study Acronym:


Brief Title:

Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia


Official Title:

Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

55 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

53


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sergio Giralt, MD
Study Chair
M.D. Anderson Cancer Center

Study Dates

Start Date:October 1994
Completion Date:April 2002
Completion Type:Actual
Primary Completion Date:April 2002
Primary Completion Type:Actual
Verification Date:July 2012
Last Changed Date:July 27, 2012
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Toxic Effects of Peripheral Stem Cell Transplantation + Filgrastim
Time Frame:24 - 36 months
Safety Issues:False
Description:Effectiveness as determined by toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy

Study Interventions

Intervention Type:Procedure
Name:Peripheral Blood Stem Cell Transplantation
Description:Cell infusion Day 0.
Arm Name:Group 1A
Other Name:PBSCT
Intervention Type:Drug
Name:Methylprednisolone
Description:Begins 5 days after infusion and is gradually tapered.
Arm Name:Group 1A
Other Name:Depo-Medrol
Intervention Type:Drug
Name:Idarubicin
Description:IV Days -6, -5 and -4.
Arm Name:Group 1A
Other Name:Idamycin
Intervention Type:Drug
Name:Fludarabine Phosphate
Description:IV over 30 minutes daily on days -6, -5, -4 and -3.
Arm Name:Group 1B
Other Name:Fludara
Intervention Type:Drug
Name:Cytarabine (Ara-C)
Description:Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
Arm Name:Group 1A
Other Name:Ara-C
Intervention Type:Drug
Name:Cyclosporine
Description:For GVHD prophylaxis, cyclosporine via continuous IV infusion. Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion. Then dose tapered 10% weekly until discontinued.
Arm Name:Group 1A
Other Name:Sandimmune
Intervention Type:Drug
Name:Cladribine
Description:Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.
Arm Name:Group 1A
Other Name:Leustatin
Intervention Type:Biological
Name:Filgrastim
Description:Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
Arm Name:Group 1A
Other Name:G-CSF

Study Arms

Study Arm Type:Experimental
Arm Name:Group 1B
Description:Group 1B: With or Without Remission, No previous Fludara Therapy Fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours. Idarubicin IV Days -6, -5 and -4. Cells infused on day 0. Cyclosporine via continuous IV infusion, oral cyclosporine administered for 6 months postinfusion (tapered 10% weekly until discontinued). Methylprednisolone begins 5 days after infusion then gradually tapered.
Study Arm Type:Experimental
Arm Name:Group 1A
Description:Group 1A - With or Without Remission + Failing Fludarabine therapy: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3 with Cladribine continuous infusion for 5 days, beginning 4 hours before Ara-C first dose. Idarubicin IV Days -6, -5 and -4. Cells infused on day 0. Cyclosporine via continuous IV infusion, oral cyclosporine administered for 6 months postinfusion (tapered 10% weekly until discontinued). Methylprednisolone begins 5 days after infusion then gradually tapered.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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