AzTrials
AzTrials

T-ALLPhase 2NCT06648889

Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia

A Phase 2 study testing Isatuximab in people with T-ALL, run by Goethe University at 15 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial summary

The planned trial offers treatment cohorts for patients with full cytologic relapse (R/R ALL - Cohort 1), as well as for patients with molecular failure/relapse (MRD+ ALL - Cohort 2). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
T-ALL
What is being tested?
Isatuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
15 sitesGermany
Study dates
22 Oct 2024to Jun 2030
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort 1:
  • Patients with CD38 positive T-ALL/T-LBL
  • Either: In relapse or with primary refractory disease defined as ≥5% blasts in bone marrow cytology or ≥1% minimal residual disease (MRD)
  • Or: Extramedullary relapse or primary refractory disease confirmed by standard imaging with measurable target leasions
  • after at least three chemotherapy cycles (induction I-II, consolidation I) with the following additional specifications:
  • early relapse within 12 months from first achievement of CR or
Show all 31Show fewer
  • late relapse later than 12 months from first achievement of CR or
  • primary refractory disease without any CR or
  • any relapse after stem cell transplantation or
  • any refractory relapse, defined as no response to at least one salvage therapy or
  • any second or later relapse and
  • Availability of patient material with blast cells (bone marrow or peripheral blood) for central MRD assessment or availability of respective predefined marker (not required in patients with extramedullary disease only).
  • ECOG status: 0-2
  • Age ≥ 18 years
  • Evidence of a personally signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study
  • Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
  • Regeneration from last chemotherapy defined as follows:
  • Platelets ≥10.000/uL (platelet transfusion allowed)
  • Hemoglobin ≥ 7.5 g/dl (red blood cell transfusion allowed)
  • Adequate liver function defined as follows:
  • Bilirubin ≤ 1.5 ULN (unless Gilbert Meulengracht disease or classified as result of liver infiltration by investigator)
  • AST and ALT ≤ 2.5 x ULN (unless classified as result of liver infiltration by investigator)
  • Adequate renal function defined as follows:
  • Serum creatinine ≤ 2 x ULN
  • Any serum creatinine level associated with a calculated creatinine clearance ≥ 40 mL/min
  • Negative pregnancy test in women of childbearing potential (WOCBP)
  • WOCBP must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously.
  • Men who are sexually active with a WOCBP must agree to use a barrier method of contraception
  • Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)
  • Cohort 2:
  • terminated with protocol version 3.2.

Who cannot join

  • Cohort 1:
  • Patients with CNS-only relapse
  • Patients who have received prior antileukemic immunotherapy within 2 weeks prior to start of Isatuximab treatment
  • Patients who have received treatment for leukemia with chemotherapy as follows:
  • Patients who have received treatment for leukemia with chemotherapy within 2 weeks prior to start of Isatuximab treatment (exception: documented disease progression under chemotherapy and pre-phase therapy with 5-7 days of Dexamethasone, 3 days of Cyclophosphamide; intrathecal prophylaxis)
  • Patients who are candidates for a treatment with Nelarabine (eligibility to be assessed particularly in patients with extramedullary involvement and/or early/mature T-ALL/T-LBL, due to limited efficacy)
Show all 22Show fewer
  • Patients must have recovered from acute non-hematologic toxicity form previous therapies to ≤ grade I unless signs or symptoms are correlated to leukaemia involvement
  • Prior SCT ≤ 3 months from start of study treatment
  • Acute GvHD ≥ grade II or active chronic GvHD requiring systemic treatment
  • Any systemic GvHD prophylaxis or treatment within 2 weeks from start of study treatment
  • Known HIV positivity, known hepatitis B surface antigen positivity or known history of hepatitis C
  • Unstable or severe uncontrolled medical condition e.g. unstable cardiac function or unstable pulmonary condition
  • Treatment with an investigational agent within 4 weeks from start of study treatment (safety follow-up period of respective study)
  • Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been treated with radiation or surgery; patients with previous malignancies are eligible if they have been disease free for ≥ 2 years and do not require any antitumor therapy
  • Evidence of uncontrolled current serious active infection or recent history (within 4 months) of deep tissue infections such as fasciitis or osteomyelitis
  • Known allergies, hypersensitivity, or intolerance to Boron or Mannitol, corticosteroids, mAb (including Isatuximab) or human proteins, or their excipients (refer to respective Summary of Product Characteristics), or known sensitivity to mammalian-derived products
  • Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
  • Pregnant or breastfeeding females
  • Vaccination with live attenuated vaccines within 4 weeks of first study agent administration
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study
  • Cohort 2:
  • terminated with protocol version 3.2.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicola Goekbuget, MD contact

0049-6963016365

goekbuget@em.uni-frankfurt.de

15 sites in 1 country

Germany15 sites, 15 recruiting

  • University Hospital Augsburg, II. Medizinischen Klinik, Hämatologie, internistische Onkologie und Hämostaseologie

    Augsburg, 86156

    Andreas Rank, MD

    Andreas Rank, MD

    Recruiting

  • Charité Berlin, Campus Benjamin Franklin, Department of Hematology, Oncology and Tumorimmunologyt Hämatologie

    Berlin, 12203

    Stefan Schwartz, MD

    Stefan Schwartz, MD

    Recruiting

  • Gesundheit Nord Klinikverbund Bremen gGmbH, Klinikum Bremen-Mitte, Med. Klinik I

    Bremen, 28205

    Maher Hanoun, Prof. M.D.

    Maher Hanoun, Prof. M.D.

    Recruiting

  • Klinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik I

    Dresden, 01307

    Lisa Heberling, MD

    Lisa Heberling, MD

    Recruiting

  • University Hospital Düsseldorf, Department of Hematology, Oncology and Clinical Immunology

    Düsseldorf, 40225

    Kathrin Nachtkamp, MD

    Kathrin Nachtkamp, MD

    Recruiting

  • University Hospital Erlangen AöR, Department of Medicine 5

    Erlangen, 91054

    Bernd Spriewald, MD

    Bernd Spriewald, MD

    Recruiting

  • Goethe University Hospital Frankfurt, Department of Medicine, Hematology and Oncology

    Frankfurt am Main, 60580

    Nicola Goekbuget, MD, 0049-6963016365, goekbuget@em.uni-frankfurt.de

    Anjali Cremer, MD

    Recruiting

  • University Hospital Hamburg-Eppendorf, Department of Medicine II

    Hamburg, 20251

    Franziska Westendorf, MD

    Franziska Westendorf, MD

    Recruiting

  • University Hospital Heidelberg, Department V, Hematology, Oncology and Rheumatology

    Heidelberg, 69120

    Simon Raffel, MD

    Simon Raffel, MD

    Recruiting

  • University Hospital Schleswig-Holstein, Campus Kiel, Medical Department II

    Kiel, 24105

    Lars Fransecky, MD

    Lars Fransecky, MD

    Recruiting

  • University Hospital Leipzig; Klinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Bereich Hämatologie und Zelltherapie

    Leipzig, 04103

    Georg-Nikolaus Franke, MD

    Georg-Nikolaus Franke, MD

    Recruiting

  • University Hospital München-Großhadern, Medizinische Klinik und Poliklinik III

    München, 81377

    Veit Bücklein, MD

    Veit Bücklein, MD

    Recruiting

  • University Hospital Münster, Medizinische Klinik A / KMT-Zentrum

    Münster, 48149

    Matthias Stelljes, MD

    Matthias Stelljes, MD

    Recruiting

  • Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Onkologie und Hämatologie

    Oldenburg, 26135

    Andreas Voß, MD

    Andreas Voß, MD

    Recruiting

  • Robert-Bosch-Krankenhaus; Abteilung für Hämatologie, Onkologie und Palliativmedizin

    Stuttgart, 70376

    Sonja Martin, MD

    Sonja Martin, MD

    Recruiting

Other trials in Germany

About this study

Official title: A Multicenter, Single-arm Phase II Study to Assess the Safety, Tolerability, and Efficacy of Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia (GMALL-Isatuximab)

The planned trial offers treatment cohorts for patients with full cytologic relapse (R/R ALL - Cohort 1), as well as for patients with molecular failure/relapse (MRD+ ALL - Cohort 2). Basically, the study aims to develop data for optimization of first-line therapy of T-ALL, either by modification of standard induction with Isatuximab or by establishing a post-induction therapy for eradication of MRD and thereby evaluates in parallel two different strategies.

Conditions
T-ALL
Being tested
Isatuximab
Keywords
R/R or MRD CD38-positive T-ALL
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IsatuximabDrug

    Also called Bortezomib

    Cohort 1: All patients will receive two cycles of induction therapy with standard chemotherapy, Bortezomib and Isatuximab. Isatuximab maintenance may be administered in patients with CR until SCT, progression/relapse, unacceptable toxicity, physicians' decision to change treatment or withdrawal of consent.

  • IsatuximabDrug

    Cohort 2: All patients will receive at least one cycle with Isatuximab. Each cycle will be 4 weeks in duration. Isatuximab will be administered until SCT, hematologic relapse including extramedullary, unacceptable toxicity, physicians' decision, or withdrawal of consent - terminated with protocol version 3.2.

Study groups in NCT06648889
Study groupRoleWhat they receive
GMALL-IsatuximabExperimentalCohort 1: In this Cohort, Isatuximab shall be implemented as part of a combination therapy for patients with R/R T-ALL/T-LBL, defined as bone marrow infiltration of ≥5% (R/R T-ALL) or ≥1% minimal residual disease (MRD). Cohort 2: In this Cohort, Isatuximab shall be implemented as single drug treatment for patients with molecular failure/relapse. Cohort 2 will include patients with hematologic remission (bone marrow blast count <5%) of T-cell ALL, but with molecular failure or molecular relapse (MRD+ T-ALL) - terminated with protocol version 3.2.
Receives: Drug: Isatuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with complete hematologic response (ORR= CR and CRi)

    Cohort 1: Proportion of patients with complete hematologic response (ORR= CR and CRi) after 2 cycles of induction therapy including Isatuximab.

    Measured: Day 22, Week 9, per SoC

  2. Overall incidence and severity of adverse events

    Cohort 1: Overall incidence and severity of adverse events (CTCAE 5.0).

    Measured: Day 22, Week 9, month 3, month 6 (depends on duration of therapy which is variable)

  3. Proportion of patients with molecular response (MolCR)

    Cohort 2:

    Proportion of patients with molecular response (MolCR) after one cycle of Isatuximab.

    Measured: Day 22, Week 9, per SoC

Secondary outcomes (14)

  1. Proportion of patients with CR and CRi, MolCR and cMolCR in R/R

    Cohort 1: Proportion of patients with CR and CRi, MolCR and cMolCR in R/R (cohort 1) after 1 or 2 cycles of induction (best response)

    Measured: Day 22, Week 9, per SoC

  2. Probability of continuous complete remission

    Probability of continuous complete remission (remission duration) at 18 months

    Measured: at 18 months

  3. Probability of overall survival

    Probability of overall survival at 18 months

    Measured: at 18 Months

  4. Probability of relapse-free survival

    Probability of relapse-free survival at 18 months

    Measured: at 18 months

  5. Probability of event-free survival

    Probability of event-free survival at 18 months

    Measured: at 18 months

  6. Incidence of relapses and proportion of relapse localisations

    Incidence of relapses and proportion of relapse localisations

    Measured: Day 22, Week 9, per SoC

  7. Incidence of GvHD in patients with prior SCT

    Incidence of GvHD in patients with prior SCT

    Measured: until end of trial

  8. Duration of molecular remission (mimimal residual disease by PCR)

    Measured: Day 22, Week 9, per SoC

  9. Treatment realization for Isatuximab

    Dosing of Isatuximab as scheduled per protocol

    Measured: d22, week 9, per maintenance cycle, end of treatment at month 6

  10. Probability of continuous MolCR and cMolCR and duration of MolCR and cMolCR

    Probability of continuous MolCR and cMolCR and duration of MolCR and cMolCR

    Measured: Day 22, Week 9, per SoC

  11. Time to MolCR and cMolCR

    Time to MolCR and cMolCR measured by time-point of first achievement.

    Measured: Day 22, Week 9, per SoC

  12. Conduct of SCT in patients with CR (ORR), MolCR, cMolCR

    The conduct of SCT will be assessed in patients with CR (ORR), MolCR, cMolCR, SCT parameters and outcome

    Measured: Through completion of the trial, average 18 months

  13. Measurement of Quality of Life

    Measurement of Quality of Life with EORTC instruments (e.g. EORTC QLQ-C30) at different time-points during treatment

    Measured: Day 22, Week 9

  14. Hospitalisation days

    Hospitalisation days

    Measured: Day 22, Week 9, month 3 and 6 (depending on treatment duration which is individual)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start22 Oct 2024
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06648889
Sponsor's protocol ID
GMALL-Isatuximab
Other IDs
2023-507899-47-00, 2023
Status last verified
Jan 2026
First submitted
15 Jul 2024
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in