Clinical trial · Interventional
Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)
Treatment of Peripheral T-cell Lymphoma With Aggressive Induction Chemotherapy Followed by Autologous Stem Cell Transplant Using Denileukin Diftitox (Ontak) for In-vivo Purging and Post-Transplant Therapy: A Multicenter Phase II Clinical Trial
NCT00632827CI-TRIAL-00044833terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Manufacturing shortage of both Diftitox and Doxil
Summary
Brief summary (as posted)
This study examines the use of denileukin diftitox (Ontak) for patients with peripheral T-cell lymphoma who are candidates for autologous stem cell transplants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carmustine | Drug | Carmustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Denileukin diftitox | Drug | — | UNRESOLVED |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Doxorubicin Hydrochloride Liposome Injection | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Plan
- description
- (1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days (D) 1, 8, Navelbine 20 mg/m2 D1, D8; Doxil 15 mg/m2 Days 1 and 8, G-CSF Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion (CIVI), days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day -6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion D0 (7) Post-transplant: Denileukin Diftitox (Ontak) 18 mcg/kg/day days 1- 5
- interventionNames
- Drug: Gemcitabine
- Drug: Navelbine
- Drug: Doxorubicin Hydrochloride Liposome Injection
- Drug: Granulocyte-colony stimulating factor (G-CSF)
- Drug: Pegfilgrastim
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Leucovorin
- Drug: Methotrexate
- Drug: Doxorubicin Hydrochloride
- Drug: Cytarabine
- Drug: Etoposide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of any of the following: * Peripheral T-cell lymphoma not otherwise specified (PTCL-U),(IPI \>2) * Angioimmunoblastic T-cell lymphoma (AILT) (IPI \>2) * Non-primary cutaneous Alk-1-negative anaplastic large cell lymphoma * Extranodal natural killer (NK)/T lymphoma (Excluding stage I/II nasal disease) * Blastic NK cell lymphoma * Enteropathy type T-cell lymphoma * Cutaneous panniculitis-like T-cell lymphoma * Hepatosplenic T-cell lymphoma * Measurable or assessable disease is not required. * Age ≥ 18 and ≤ 70 years * Previously untreated or 1 prior cycle of chemotherapy * Creatinine \< 2.0 mg/dL * Total bilirubin \< 2.0 mg/dL, aspartate aminotransferase (AST) \< 3x upper limit of normal * Patients who test positive for Hepatitis B surface Ag (HepBSAg) or Hepatitis C antibody (HepCAb) are eligible provided all of the following criteria are met: * bilirubin ≤ 2 x upper limit of normal; * aspartate aminotransferase (AST) ≤ 3 x upper limit of normal; * liver biopsy demonstrates ≤ grade 2 fibrosis and no cirrhosis. Hepatitis B surface Ag(+) patients will be treated with lamivudine (3TC) or investigator's preferred antiviral regimen throughout protocol therapy and for 6-12 months thereafter. * Neutrophils ≥ 1000/microlitre (uL) platelets \> 100,000/uL * HIV-negative * Left ventricular ejection fraction (LVEF) of ≥ 45% * No known hypersensitivity to denileukin diftitox or any of its components: diptheria toxin, interleukin-2, or excipients * Non-pregnant, non-nursing: Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control. * Patients with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible. (This includes Waldenstrom's Macroglobulinemia, since such patents have experienced transient increases inImmunoglobulin M (IgM) following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis). Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse. Exclusion Criteria: * PTCL-U / AILT with IPI 0 or 1 Extranodal NK/T nasal stage I/II T-lymphoblastic lymphoma Adult T-cell leukemia/lymphoma * Adult T-cell leukemia/lymphoma
References
Publications (0)
Data not yet available
No reference posted for this study.