Trials / Completed
CompletedNCT04121507
ASTRAL- a Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy
A Prospective Phase II Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy Followed by Allogeneic Stem Cell Transplantation as Treatment of Primary Progressive and Relapsed Aggressive Non-Hodgkin Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- GWT-TUD GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective Phase II clinical study to assess the efficacy and toxicity of high dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (allo- or autoSCT) as treatment of primary progressive and relapsed aggressive Non-Hodgkin Lymphoma (NHL) - ASTRAL
Detailed description
This is a clinical study to assess the treatment (efficacy and toxicity) with a high dosed chemotherapy followed by stem cell transplantation in patients suffering from primary progressive and relapsed aggressive Non-Hodgkin Lymphoma (NHL) After end of the active study phase, patients will receive further standard medical care at the discretion of the treating physician. The clinical consultants will provide advice on further treatment if requested.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | High dose chemotherapy before allogeneic stem cell transplantation (alloSCT) | High-dose therapy (HDT) prior to alloSCT will consist of FTC |
| PROCEDURE | Bone marrow histology | Bone marrow histology at staging and restaging is only mandatory if the bone marrow was initially involved |
| DIAGNOSTIC_TEST | clinical and laboratory parameters | During staging and restaging examinations, all clinical and laboratory parameters relevant for therapy. |
| DIAGNOSTIC_TEST | PET-CT or CT | Metabolic CR in a PET-CT scan after the last cycle of therapy prior to planned SCT. Consists preferably of a PET-CT or a CT scan according to local practice and other appropriate diagnostic procedures with respect to the sites of primary involvement. |
Timeline
- Start date
- 2019-06-24
- Primary completion
- 2022-03-30
- Completion
- 2023-02-02
- First posted
- 2019-10-10
- Last updated
- 2023-05-24
Locations
13 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04121507. Inclusion in this directory is not an endorsement.