Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas

NCT02859402 | Recruiting Phase 2

• 1 other identifier: DSMC 2016-05-051
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role of allogeneic stem cell transplantation have been demonstrated in these patients. This clinical trial is studying the efficacy and safety of busulfan plus fludarabine as conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies including autologous transplantation.

Conditions

T-cell Non-Hodgkin Lymphoma; Lymphoma, Extranodal NK-T-Cell

Keywords

T-cell Non-Hodgkin Lymphoma; NK/T-cell Non-Hodgkin Lymphoma; Relapsed, refractory; Conditioning; Allogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival

  2 year progression-free survival rate from the date of allogeneic stem cell transplantation. Estimated using the Kaplan-Meier method. Median value will be provided.

  2 years

Secondary Outcomes (10)

• Response rate

  3-months

• Time to neutrophil engraftment

  Day 30

• Time to platelet engraftment

  Day 30

• 2-year overall survival

  2 years

• 100-days treatment-related mortality

  Days 100

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Conditioning chemotherapy: Fludarabine and Busulfan followed by Allogeneic stem cell transplantation

Drug: Busulfan; Drug: Fludarabine

Interventions

Busulfan DRUG

intravenous, 3.2 mg/kg + 5% DW (the diluent quantity should be 10 times the volume of Busulfan, so that the final concentration of busulfan becomes approximately 0.5 mg/mL), once daily for 3 hours for 3 days (days -7 to -5)

Also known as: Busulfex

Experimental Arm

Fludarabine DRUG

intravenous, 30 mg/m2 + 5% DW 100㎖, over 1 hour once daily for 6 days (days -8 to -3)

Experimental Arm

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 - 65
• Histologically confirmed T or NK cell lymphomas :
• anaplastic large cell lymphoma
• angioimmunoblastic T-cell lymphoma,
• peripheral T-cell lymphoma, NOS
• NK/T-cell lymphoma
• Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT.
• At least one measured lesion using conventional CT or PET CT at the time of relapse after or refractory to one or more of previous chemotherapy and before salvage chemotherapy
• Complete or Partial response after short cycles of salvage chemotherapy
• Patients who have HLA full-match (8/8 in HLA-A, B, C, DR by DNA high-resolution technique) or one-locus mismatch (7/8) sibling, or unrelated bone marrow or peripheral blood or cord blood stem cell donors
• ECOG performance status ≤ 2
• Charlson Comorbidity Index (CCI) before HSCT ≤ 3
• Adequate renal function : serum creatinine level \< 2.0 mg/dL
• Adequate liver function :
• Transaminase (AST/ALT) \< 3 X upper normal value (or \< 5 x ULN in the presence of lymphoma involvement of the liver)

You may not qualify if:

• Adult T cell leukemia/lymphoma, Lymphoblastic lymphoma, Primary cutaneous CD30+ T cell disorders Mycosis fungoides, Sezary SD
• Patients who have previously performed Allo-HSCT
• T cell lymphoma with primary central nervous system (CNS) Involvement.
• \*\* However, patients who have only had prophylactic intrathecal or intravenous chemotherapy against CNS disease are eligible.
• Patients with a known history of HIV seropositivity or HCV (+).
• \*\* Patients with HBV are eligible. However, primary prophylaxis using antiviral agents is recommended for HBV carrier or prevent HBV reactivation during whole treatment period.
• Any other malignancies within the past 5 years
• \*\* Except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
• Ejection fraction \< 50% by a echocardiography
• FEV1 \<60% or DLCO \<60% by a pulmonary function test
• ECOG performance status 3 or 4
• Combined serious medical problem or disease
• Serious or unstable heart disease although proper treatment
• Myocardial infarction in recent 3 months
• Underlying serious neurologic or psychiatric disease including dementia or seizure

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Dong-A University

Busan, 602-713, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, Extranodal NK-T-Cell; Recurrence

Interventions

Busulfan; fludarabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Young Rok Do, MD., Ph.D.

CONTACT

+82-10-3541-1160; dyr1160@dsmc.or.kr

Ji Hyun Lee, MD., Ph.D.

CONTACT

+82-10-9397-5694; hidrleejh@dau.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 9, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

KR (2)