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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia Lymphoma Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flu-Mel

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.

Group Type NO_INTERVENTION

Flu-Mel

Intervention Type DRUG

* 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.

Interventions

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Flu-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.

Intervention Type DRUG

Other Intervention Names

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Fludara-Alkaran

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No