Allogeneic stem cell transplantation for relapsed T- and NK/T-cell lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.