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BDH-WM03: Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia

Sponsor
Institute of Hematology & Blood Diseases Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02844361
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
48
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether autologous stem cell transplantation will improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with conventional chemotherapy.

Condition or Disease Intervention/Treatment Phase
  • Other: autologous stem cell transplantation
  • Other: conventional chemotherapy
 Phase 4

Detailed Description

WM patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). After transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: autologous stem cell transplantation

Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback

Other: autologous stem cell transplantation
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
Active Comparator: conventional chemotherapy

Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy

Other: conventional chemotherapy
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy

Outcome Measures

Primary Outcome Measures

  1. progress-free survival [up to 36 months]

Secondary Outcome Measures

  1. complete remission rate [up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. 70 years>=Aged >=18 years

  2. diagnosed with high-risk LPL/WM according to the ISSWM criteria

  3. untreated or mild treated without standard regimens

  4. suitable for ASCT

  5. with life-expectancy more than 3 months.

Exclusion Criteria:

  1. diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma)

  2. transformed lymphoma

  3. liver or renal function lesion unrelated to lymphoma

  4. serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician

  5. HIV positive or active HBV infection or other uncontrolled systematic infection

  6. clinical central nervous dysfunction

  7. serious surgery within 30 days

  8. pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shuhua Yi Tianjin China 300020

Sponsors and Collaborators

  • Institute of Hematology & Blood Diseases Hospital

Investigators

  • Principal Investigator: Shuhua Yi, Doc, blood disease hospital, Chinese Academic Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yi Shuhua, Principal Investigator, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier:
NCT02844361
Other Study ID Numbers:
  • ITT2015006-EC-2
First Posted:
Jul 26, 2016
Last Update Posted:
Jul 26, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Yi Shuhua, Principal Investigator, Institute of Hematology & Blood Diseases Hospital
high-risk
ASCT
Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia

Study Results

No Results Posted as of Jul 26, 2016