Clinical trial · Interventional
Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkin's Lymphoma (NHL)
An Open Phase I Single Dose Escalation Study of BI 2536 Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating patients with refractory or relapsed advanced non-Hodgkin's lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BI 2536 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course
- timeFrame
- up to 22 days of each course
- measure
- Dose-limiting toxicity as measured by CTCAE v3.0 at days 1-22 of each course
- timeFrame
- up to 22 days of each course
Secondary outcomes (2)
- measure
- Objective tumor response by CT scan or MRI as measured by RECIST criteria on day 22 of each even numbered course
- timeFrame
- day 22 of every second course
- measure
- Pharmacokinetics as measured in blood samples at days 1, 2, 3, and 8 during first course and on day 1 of each subsequent course
- timeFrame
- day 22 of each course
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed advanced aggressive non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
* B-cell NHL, including any of the following subtypes:
* Diffuse large B-cell lymphoma
* Primary mediastinal (thymic) B-cell lymphoma
* Intravascular large B-cell lymphoma
* Immunoblastic B-cell lymphoma
* Mantle cell lymphoma
* Burkitt's lymphoma
* Follicular grade 3b lymphoma
* T-cell NHL, including any of the following subtypes:
* Anaplastic large cell lymphoma
* Peripheral T-cell lymphoma, not otherwise specified
* De novo or transformed disease
* Refractory (i.e., disease not amenable to standard therapy) or relapsed disease, as evidenced by 1 of the following:
* Refractory to OR relapsed after ≥ 1 prior combination chemotherapy regimen
* Refractory to OR relapsed after prior CD20-based immunotherapy (for patients eligible to receive such therapy)
* Refractory after prior high-dose chemotherapy and autologous stem cell transplantation AND ≥ 100 days post transplantation
* At least 1 bidimensionally measurable lesion ≥ 1.5 cm by CT scan, MRI, x-ray, or clinical examination
* No active CNS lymphoma
PATIENT CHARACTERISTICS:
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* No known coagulopathy
Hepatic
* ALT and/or AST ≤ 2.5 times upper limit of normal (ULN) (\< 5 times ULN if due to hepatic lymphoma)
* Bilirubin ≤ 1.5 times ULN
Renal
* Creatinine ≤ 2.0 mg/dL
Immunologic
* No known HIV infection
* No serious active infection that requires IV antibiotics or antifungal or antiviral agents
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception during and for 1 year after completion of study treatment
* No known or suspected alcohol or drug abuse
* No sensory or motor neuropathy ≥ grade 3
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No other life-threatening illness or organ dysfunction that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* See Radiotherapy
* More than 3 weeks since prior and no concurrent immunotherapy
* No prior allogeneic bone marrow transplantation
Chemotherapy
* See Disease Characteristics
* More than 3 weeks since prior and no concurrent chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
* No concurrent hormonal therapy
Radiotherapy
* No prior radiotherapy to the only site of measurable disease unless there is documented disease progression after completion of radiotherapy
* More than 8 weeks since prior and no concurrent systemic radioimmunotherapy
* More than 3 weeks since prior and no concurrent radiotherapy
* Concurrent palliative radiotherapy to sites other than the only measurable target lesion allowed for symptom control provided the reason for radiotherapy does not reflect progressive disease
Other
* No concurrent warfarin for therapeutic anticoagulationReferences
Publications (0)
Data not yet available