NCT00772811

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

9.2 years

First QC Date

October 5, 2008

Last Update Submit

February 16, 2011

Conditions

Chronic Lymphocytic LeukemiaLymphomaMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

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

    -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.

    9years

Secondary Outcomes (1)

  • include tumor response, incidence of chronic GVHD, and immune reconstitution.

    9years

Study Arms (1)

Flu-Mel

NO INTERVENTION

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.

Drug: Flu-Mel

Interventions

Flu-MelDRUG

* 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.

Also known as: Fludara-Alkaran
Flu-Mel

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Lee KH. A Phase II Trial of Fludarabine/Melphalan 100 Conditioning Therapy Followed by Allogeneic Hematopoietic Cell Transplantation for Patients With Lymphoma. Clin Lymphoma Myeloma Leuk. 2015 Nov;15(11):655-63. doi: 10.1016/j.clml.2015.08.087. Epub 2015 Sep 3.

    PMID: 26428486DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphomaMultiple Myeloma

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Je-Hwan Lee, Doctor

    COSAH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

October 5, 2008

First Posted

October 15, 2008

Study Start

July 1, 2001

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations

KR(1)