Skip to content

Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma

Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00772811
Acronym
Flu-Mel
Enrollment
38
Registered
2008-10-15
Start date
2001-07-31
Completion date
2010-12-31
Last updated
2011-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma

Brief summary

Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

Detailed description

Treatment plan * Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2. * Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL. * Melphalan will be administered following the completion of Fludarabine infusion at day -2. * In case of unrelated donor HCT, thymoglobuline 3 mg/kg in N/S 500 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500 mL (less than 2 mg/mL) IV qd on days -4, -3 and -2. Infuse over 4 hrs. Premedicate with Avil 45.5 mg IVP and Tylenol 600 mg po. Methylprednisolone 2 mg/kg in D5W 100 ml will be given IV over 30 minutes before thymoglobulin (or lymphoglobuline) on days -4 to -2. * Before the administration of melphalan, prehydration will be done intravenously with 0.9% NS 1L over 3 hours. * 30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan 1 mg i.v. push will be given. Appropriate antiemetics such as ondansetron 8 mg i.v. push every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered. * Hydration with 0.9% NS at 80 mL/hour will be administered for at least 7 days. Appropriate amount of KCl should be mixed. * GVHD prophylaxis will include cyclosporine A (CSA) and methotrexate.

Interventions

DRUGFlu-Mel

* Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL. * Melphalan will be administered following the completion of Fludarabine infusion at day -2.

Sponsors

Cooperative Study Group A for Hematology
Lead SponsorNETWORK

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients must be 15 years of age or older and 65 years of age or younger * Patients with CLL, lymphoma, or multiple myeloma will be included in this study * No prior anti-cancer treatment should be done within 30 days. * Informed consent should be given. * Patients should have an HLA-identical or single HLA-locus mismatched donor. * Karnofsky performance scale should be 50 or over (see Appendix I).

Exclusion criteria

* Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the stem cell transplant treatment unlike, and making informed consent impossible. * Patients with high serum creatinine level will be excluded. * Patients should have uncontrolled infection. * No major anticipated illness or organ failure incompatible with survival from stem cell transplant. * Serum bilirubin less than or equal to 4.0 mg/dL.

Design outcomes

Primary

MeasureTime frameDescription
To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM)9years-To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) following allogeneic nonmyeloablative stem cell transplantation using fludarabine and melphalan conditioning regimen in patients with chronic lymphocytic leukemia (CLL), lymphoma, and multiple myeloma.

Secondary

MeasureTime frameDescription
include tumor response, incidence of chronic GVHD, and immune reconstitution.9years-The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026