Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies

Lymphoid Malignancies Clinical Trial

Official title:

Fludarabine/Busulfan and Post-infusion Cyclophosphamide as Conditioning for Adult Patients With Lymphoid Malignancies Undergoing Allogeienc Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435447
• Other study ID #: RJH-ALL-2011
• Status: Completed
• Phase: Phase 2
• Start date: April 2011
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in CR2. In this study, the investigators aim to further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as consolidation for lymphoid malignancies and graft-versus-host disease (GVHD) prophylaxis.

Description:

Patients with adult lymphoid malignancies received conditioning with Fludarabine + iv-BU. The GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all patients after D+5.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 1, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• adult acute lymphocytic leukemia in 1st or second remission; lymphoid malignancies in 1st or second remission

• age 16-60 years

• with inform consent

• no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage

• HLA matched related (6/6), unrelated donors (at least 8/10) or mismatched related donor (haplo)

Exclusion Criteria:

• age less than 16 years or over 60 years

• liver function/renal function damage (over 2 X upper normal range)

• with mental disease

• other contraindication of all-HSCT

Related Conditions & MeSH terms

• Lymphoid Malignancies
• Neoplasms

Intervention

Drug:
• FLu-Bu-Cy
Fludarabine at 30mg/m2 daily followed by iv-Busulfan at 3.2mg/kg daily for a total of 4 days from Day-6 to -3 and cyclophosphamide as 60mg/kg daily for 2 days on Day +3 and +4, CSA 3mg/kg starting after D+5.

Locations

Country	Name	City	State
China	Blood and Marrow Transplantation Center, Rui Jin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute graft versus host disease (GVHD)	d100 incidence of acute GVHD, grade II-IV or grade III-IV	day 100
Primary	chronic GVHD	3-year incidence of chronic GVHD and extensive cGVHD	3 years
Secondary	non-relapse mortality (NRM)	estimated 3-year NRM after transplantation (death not due to relapse disease)	3 years
Secondary	cumulated incidence of relapse (CIR)	estimated 3-year CIR after transplantation	3 years
Secondary	event-free survival (EFS)	estimated 3-year EFS estimated 3-year EFS after transplantation	3 years
Secondary	overall survival (OS)	estimated 3-year OS after transplantation	3 years
Secondary	GVHD-free, relapse-free survival (GRFS)	estimated 3-year survival for patients without relapse, without III-IV aGVHD and without cGVHD required systemic treatment	3 years