BridgeMD
CHEMOKINE RECEPTOR CXCR4-DIRECTED THERANOSTICS OF ADVANCED LYMPHOPROLIFERATIVE CANCERS BY RADIOPEPTIDE-BASED IMAGING AND THERAPY: THE COLPRIT PHASE I/II STUDY
EU CTIS ID: 2024-517639-35-00
What this study is testing
Phase I: The definition of the max. tolerated activity by escalation of 90Y-Pentixather in combination with high dose chemotherapy according to SOC (e.g. Melphalan, Treosulfan) followed by autoSCT. Phase II: to evaluate the overall response rate (ORR) of the treatment regime established in the phase I part of the clinical trial
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven diagnosis of one of the following active measurable lymphoproliferative malignancies (as defined in chapter 10.1): a) Multiple myeloma (progression after conventional chemotherapy, at least one proteasome inhibitor and one immunomodulatory drug, and high-dose chemotherapy with autoSCT, not currently suitable for allogeneic hematopoietic stem cell transplantation [alloSCT]) b) Aggressive B- and T-NHL including heavily pretreated transformed indolent lymphoma (tNHL) (refractory or relapsed disease after extensive pretreatment with min. 2 regimes, at least one including an anti-CD20 antibody, or after standard high-dose chemotherapy with autoSCT), not currently suitable for alloSCT
- Written informed consent
- Inclusion of patients with preceded CAR-T cell therapy is allowed but not a perquisite if such a therapy is not indicated or available at the time point of inclusion
- Positive 68Ga -Pentixafor PET/CT imaging. In patients with MM 68Ga-Pentixafor-PET/CT may be replaced by 68Ga-Pentixafor-PET/MR
- Bone marrow aspirate and biopsy (according to clinical routine from last lymphom/myelom specific therapy or 3 - 4 months prior to Baseline) for assessment of pathology, cytology and immunohistochemistry and/or flow cytometry for CXCR4 (CD184) expression
- Availability of CD34+ peripheral blood hematopoietic stem cells (CD34+ HSC), > 2x106 CD34+HSC / kg body weight) prior to enrolment, obtained during a previous treatment line, including HSC intended for backup use
You likely can't join if
- Evidence of active concurrent malignant disease
- Evidence of rapid progress of underlying diseases with severely limited life expectancy (< 3 months)
- Evidence of significant, uncontrolled acute or chronic concomitant diseases that could affect compliance with the protocol or interpretation of results including contraindications against CT-/MRI-/PET-Scans or against myeloablative therapy followed by autoSCT
- Study participants with discrepant lesions in FDG PET cannot be included
- Uncontrolled active or chronic infection, including hepatitis B and/or C (Anti-HbS, HbSAG) and HIV (Anti-HIV)
- Patients with a history of psychiatric illness or condition that could interfere with their ability to understand the requirements of the clinical trial
See the full eligibility criteria
Who can join
- Histologically proven diagnosis of one of the following active measurable lymphoproliferative malignancies (as defined in chapter 10.1): a) Multiple myeloma (progression after conventional chemotherapy, at least one proteasome inhibitor and one immunomodulatory drug, and high-dose chemotherapy with autoSCT, not currently suitable for allogeneic hematopoietic stem cell transplantation [alloSCT]) b) Aggressive B- and T-NHL including heavily pretreated transformed indolent lymphoma (tNHL) (refractory or relapsed disease after extensive pretreatment with min. 2 regimes, at least one including an anti-CD20 antibody, or after standard high-dose chemotherapy with autoSCT), not currently suitable for alloSCT
- Written informed consent
- Inclusion of patients with preceded CAR-T cell therapy is allowed but not a perquisite if such a therapy is not indicated or available at the time point of inclusion
- Positive 68Ga -Pentixafor PET/CT imaging. In patients with MM 68Ga-Pentixafor-PET/CT may be replaced by 68Ga-Pentixafor-PET/MR
- Bone marrow aspirate and biopsy (according to clinical routine from last lymphom/myelom specific therapy or 3 - 4 months prior to Baseline) for assessment of pathology, cytology and immunohistochemistry and/or flow cytometry for CXCR4 (CD184) expression
- Availability of CD34+ peripheral blood hematopoietic stem cells (CD34+ HSC), > 2x106 CD34+HSC / kg body weight) prior to enrolment, obtained during a previous treatment line, including HSC intended for backup use
- Age ≥ 18 years
- Eastern cooperative oncology group (ECOG) performance status 0-1 and life expectancy > 3 months and deemed fit for high-dose chemotherapy and autologous stem-cell transplantation
- Adequate hematopoetic, hepatic (ALAT/ASAT <5x ULN, total Bilirubin <2.5x ULN), renal (CreaCl>40ml/min), cardiac and pulmonary function, excluding organ dysfunctions associated with the underlying disease.
- Women of childbearing potential (WOCBP) must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correct are for example implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence (defined as refraining from heterosexual intercourse during the clinical trial) or vasectomized partner. Those contraceptive measures should be applied for 30 days after visit 3 Men with child bearing potential (CBP) must either use a condom, must be vasectomized or stay sexual abstinent. Contraception for WOCBP – as above mentioned – should be considered. Those contraceptive measures should be applied for 90 days after visit 3.
What rules you out
- Evidence of active concurrent malignant disease
- Evidence of rapid progress of underlying diseases with severely limited life expectancy (< 3 months)
- Evidence of significant, uncontrolled acute or chronic concomitant diseases that could affect compliance with the protocol or interpretation of results including contraindications against CT-/MRI-/PET-Scans or against myeloablative therapy followed by autoSCT
- Study participants with discrepant lesions in FDG PET cannot be included
- Uncontrolled active or chronic infection, including hepatitis B and/or C (Anti-HbS, HbSAG) and HIV (Anti-HIV)
- Patients with a history of psychiatric illness or condition that could interfere with their ability to understand the requirements of the clinical trial
- Previous or concurrent participation in another clinical study involving trial medication within the preceding 12 weeks (prior to Baseline) or previous participation in this clinical trial
- Pregnancy or breast-feeding women
- Known hypersensitivity to the IMP or NIMP/AxMP or any agent given in association with this clinical trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.