Know Cancer

or
forgot password

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


Phase 2
15 Years
65 Years
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM)

Outcome Description:

-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.

Outcome Time Frame:

9years

Safety Issue:

No

Principal Investigator

Je-Hwan Lee, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

COSAH

Authority:

Korea: Food and Drug Administration

Study ID:

C-001

NCT ID:

NCT00772811

Start Date:

July 2001

Completion Date:

December 2010

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location