Allogeneic stem cell transplantation for relapsed T- and NK/T-cell lymphomas
Allogeneic Stem Cell Transplantation With 3-days Busulfan Plus Fludarabine as Conditioning in Patients With Relapsed or Refractory T-, NK/T-cell Lymphomas
This study is testing a new, less harmful treatment using stem cell transplants for people with T- and NK/T-cell lymphomas that have come back or didn’t get better with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | Keimyung University Dongsan Medical Center Academic / other |
| Drugs / interventions | chemotherapy, fludarabine |
| Locations | 2 sites (Busan and 1 other locations) |
| Trial ID | NCT02859402 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a reduced toxicity conditioning regimen using busulfan and fludarabine followed by allogeneic stem cell transplantation in patients with relapsed or refractory T- and NK/T-cell lymphomas. The primary objective is to determine the 2-year progression-free survival rate of participants. Secondary endpoints include evaluating response rates, engraftment rates, overall survival, and treatment-related complications. The study aims to provide a potentially less toxic treatment option for patients who have not responded to previous therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 65 with histologically confirmed relapsed or refractory T- or NK-cell lymphomas who have previously undergone chemotherapy.
Not a fit: Patients with other types of lymphomas or those who do not meet the specific eligibility criteria, such as inadequate organ function or performance status, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and reduce treatment-related complications for patients with difficult-to-treat lymphomas.
How similar studies have performed: Previous studies have shown promising results with allogeneic stem cell transplantation in similar patient populations, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age 19 - 65
2. Histologically confirmed T or NK cell lymphomas :
* anaplastic large cell lymphoma
* angioimmunoblastic T-cell lymphoma,
* peripheral T-cell lymphoma, NOS
* NK/T-cell lymphoma
3. Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT.
4. 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
5. Complete or Partial response after short cycles of salvage chemotherapy
6. 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
7. ECOG performance status ≤ 2
8. Charlson Comorbidity Index (CCI) before HSCT ≤ 3
9. Adequate renal function : serum creatinine level \< 2.0 mg/dL
10. Adequate liver function :
* Transaminase (AST/ALT) \< 3 X upper normal value (or \< 5 x ULN in the presence of lymphoma involvement of the liver)
* Total bilirubin \< 2 X upper normal value (or \< 5 x ULN in the presence of NK/T involvement of the liver)
11. Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormality
12. No clinically significant infection
13. No clinically significant bleeding symptoms or sign
14. Patients who decided to participate in this study and signed for a written consent
Exclusion Criteria:
1. Adult T cell leukemia/lymphoma, Lymphoblastic lymphoma, Primary cutaneous CD30+ T cell disorders Mycosis fungoides, Sezary SD
2. Patients who have previously performed Allo-HSCT
3. 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.
4. 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.
5. Any other malignancies within the past 5 years
\*\* Except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
6. Ejection fraction \< 50% by a echocardiography
7. FEV1 \<60% or DLCO \<60% by a pulmonary function test
8. ECOG performance status 3 or 4
9. 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
* Active uncontrolled infection including hepatitis B and C
* Serious other medical problems observed by the doctors in charge of the patient
10. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Where this trial is running
Busan and 1 other locations
- Dong-A University — Busan, South Korea (Recruiting)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
Study contacts
- Study coordinator: Young Rok Do, MD., Ph.D.
- Email: dyr1160@dsmc.or.kr
- Phone: +82-10-3541-1160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.