Skip to content

HLA-haploidentical allogeneic stem cell transplantation for Adult T-cell leukemia/lymphoma (ATL/L) and refractory aggressive lymphoma

HLA-haploidentical allogeneic stem cell transplantation for Adult T-cell leukemia/lymphoma (ATL/L) and refractory aggressive lymphoma - HLA-haploidentical allogeneic stem cell transplantation for ATL/L and refractory aggressive lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002606
Enrollment
17
Registered
2009-10-10
Start date
2010-01-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult T-cell leukemia/lymphoma (acute type and lymphoma type) Malignant lymphoma (aggressive hodgkin and non-hodgkin lymphoma)

Interventions

Fludarabine (15mg/square meter of body surface area twice a day for 2 days and 30mg/square meter once a day for 4 days), cytarabine (2g/square meter twice a day for 2 days), Melphalan (100mg/ square m

Sponsors

Hematology, Osaka City University, Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with ATL/L or refractory malignant lymphoma lacking an HLA-identical or single-antigen mismatched related donor. 2) Patients without a HLA-haploidentical donor of family member or relative 3) >= 15 and < 70 years old 4) PS 0-1 5) Normal function of major organ 6) Informed consent 7) ATL/L or malignant lymphoma a) ATL/L: Acute or lymphoma type, PR or better b) Malignant lymphomas in WHO classification 2008 as shown below which relapsed after autologous HSCT, or which have no indication for autologous HSCT due to no sensitivity to chemotherapy or poorly controlled disease with conventional chemotherapy. Mature B-cell neoplasms B-cell PLL MCL FL transformed Advanced FL: refractory to Rituximab and chemotherapy DLBCL, NOS(except Primary DLBCL of the CNS) DLBL associated with chronic inflamation Primary mediastinal large B-cell lymphoma ALK+ large B-cell lymphoma Plasmablastic lymphoma Intravascular large-B cell lymphoma (IVL) Large B-cell lymphoma arising in HHV8-associated multicentric Castlemann disease Primary effusion lymphoma Burkitt lymphoma B-cell lymphoma unclassible Mature T cell and NK-cell neoplasms T-cell PLL T-cell large granular lymphocytic leukaemia Aggressive NK-cell leukemia Extranodal NK/T-cell lymphoma, nasal type Enteropathy-associated T-cell lymphoma Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma Primary cutaneous gamma-delta T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma Peripheral T-cell lymphoma NOS Angioimunoblastic T-cell lymphoma Anaplastic large cell lymphoma, ALK+ or ALK- Hodgkin lymphoma

Exclusion criteria

Exclusion criteria: 1) Major organ dysfunction a) Total bilirubin: >= 2.0mg/dl b) Serum creatinine: >= 2.0mg/dl c) Ejection fraction: < 50 % d) Pulmonary function test: %VC <40%, FEV1.0% <50% or SaO2 <90% on room air e) AST or ALT >= 3 x UNL 2) Uncontrolled active infection 3) Uncontrolled CNS invasion 4) Poorly controlled insulin-treated diabetes mellitus 5) Poorly controlled hypertension 6) Patients with a severe complication including heart failure, coronary failure, acute myocardial infarction within the last 3 months, liver cirrhosis and interstitial pneumonia 7) Pregnant, nursing or possible fertile woman 8) Patients with mental disorder or neurological disorder who are likely to unable to participate in the study 9) A history of hypersensitivity or allergy to any drugs in conditioning regimen of this transplant 10) HIV antibody positivity 11) Patients with history of administration of mogamulizumab 12) No indication for this study judged by physician in charge. (Note: HBs antigen positivity and HCV antibody positivity is not excluded.)

Design outcomes

Primary

MeasureTime frame
Engraftment rate

Countries

Japan

Contacts

Public ContactMika Nakamae

Osaka City University, Graduate School of Medicine Hematology (Clinical center for hematological malignancies)

crc-hematology@med.osaka-cu.ac.jp06-6645-3881

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026