Amyloid Light-chain AmyloidosisPhase 2NCT07110844
Teclistamab-Daratumumab in AL Amyloidosis
A Phase 2 study testing Teclistamab and Daratumumab and Hyaluronidase-fihj in people with Amyloid Light-chain Amyloidosis, run by Rajshekhar Chakraborty, MD at 3 sites in United States.
Trial summary
The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis. The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Amyloid Light-chain Amyloidosis
- What is being tested?
- Teclistamab and Daratumumab and Hyaluronidase-fihj
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Nov 2025to Oct 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide informed consent due to medical, cognitive, or other conditions, a legally authorized representative (LAR) may consent on their behalf.
- Ability to comply with the study protocol, in the investigator's judgment.
- Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a tissue biopsy that is positive for Congo Red.
- Patient must not have received any prior plasma cell clone-directed therapy.
- Measurable hematologic disease, defined as one of the following:
- Difference between involved and uninvolved serum free light chain (dFLC) ≥50 mg/L and/or 5 mg/dL
Show all 19Show fewer
- Serum M-protein ≥0.5 g/dL on protein electrophoresis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- One or more organs involved by AL amyloidosis as per consensus guidelines
- Pre-treatment clinical laboratory values meeting the following criteria during the screening phase:
- Absolute neutrophil count ≥0.75 × 10^9/L
- Hemoglobin level ≥8.0 g/dL; red blood cell transfusion allowed until 7 days before C1D0.
- Platelet count ≥50 × 10^9/L; Platelet transfusions are acceptable without restriction during the Screening period
- Alanine aminotransferase level (ALT) ≤2.5 times the Upper Limit of Normal (ULN)
- Aspartate aminotransferase (AST) ≤2.5 times the ULN
- Total bilirubin level ≤1.5 × ULN except for subjects with Gilbert syndrome, in which case direct bilirubin ≤2 × ULN
- Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m^2, measured by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs.
- For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Who cannot join
- Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0.
- Patients meeting criteria for symptomatic multiple myeloma by any one of the following: (a) Lytic lesions on imaging (Skeletal survey, whole body CT or MRI, or PET/CT) (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, (d) Bone marrow plasma cell infiltrate of greater than 60%.
- Patients with involved/uninvolved serum FLC ratio>100 as the sole myeloma-defining event will be allowed.
- Evidence of significant cardiovascular conditions as specified below:
- NT-Pro BNP > 8500 pg/mL, and/or
- NYHA Class IIIb or IV functional class
Show all 14Show fewer
- History of other malignancy that could affect compliance with the protocol or interpretation of results.
- Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, breast cancer, or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment.
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal).
- Patients on renal replacement therapy
- Patients with HIV who are not on HAART or those with active hepatitis A, B, or C infection.
- Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted, as per investigators' discretion.
- Known hypersensitivity to any of the agents
- Patients who are receiving any other investigational agent concurrently.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Boston Medical Center
Boston, Massachusetts, 02118
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Anita D'Souza, MD, MS
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Research Nurse Navigator, RN, 646-317-4840, cancerclinicaltrials@cumc.columbia.edu
Rajshekhar Chakraborty, MD
About this study
Official title: A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis
The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis.
The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.
Read the detailed description
The purpose of this study is to assess the effectiveness and safety of teclistamab-daratumumab combination in newly diagnosed AL amyloidosis. The study aims to evaluate whether this combination is able to effectively decrease the level of toxic amyloid-producing light chains circulating in the participants' blood, with the overarching goal of avoiding organ damage, improving organ function, and prolonging life.
- Conditions
- Amyloid Light-chain Amyloidosis
- Being tested
- Teclistamab, Daratumumab and Hyaluronidase-fihj
- Keywords
- Untreated AL Amyloidosis, untreated light chain amyloidosis, light chain amyloidosis, AL Amyloidosis
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Also called TECVAYLI, teclistamab-cqyv
Teclistamab is a T-cell redirecting bispecific antibody (BsAb) targeting CD3 on T-cells and B-cell maturation antigen (BCMA) on plasma cells.
Daratumumab and Hyaluronidase-fihjDrug
Also called DARZALEX FASPRO, Daratumumab
Daratumumab is an monoclonal antibody that targets the CD38 protein on the surface of myeloma cells.
| Study group | Role | What they receive |
|---|---|---|
| Teclistamab-Daratumumab | Experimental | All participants in this study will receive teclistamab and daratumumab. Receives: Drug: Teclistamab; Drug: Daratumumab and Hyaluronidase-fihj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic Complete Response (Heme-CR) rate
Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response.
Measured: 6 months from treatment initiation
Secondary outcomes (25)
Minimal Residual Disease (MRD) negativity rate by Free Light Chain Mass Spectrometry (FLC-MS) in serum
Secondary outcome is to assess the rate of minimal residual disease (MRD)-negativity and sustained MRD-negativity with Teclistamab-Daratumumab
Measured: 1 month, 3 months, 6 months, and 18 months
MRD-negativity rate by multiparameter flow cytometry (MFC) in bone marrow
The MRD-negativity rate by 6 and 18 months will be reported descriptively.
Measured: 6 months and 18 months
Time to heme-CR
Time to heme-CR will be calculated from the day of treatment initiation (C1D0), and will be reported as median (range).
Measured: Day 1 of each cycle, and every 6 weeks after treatment cessation (up to 1 year)
Major organ deterioration-progression-free survival (MOD-PFS) rate
MOD-PFS will be calculated as a time-to-event endpoint using Kaplan-Meier method.
Measured: From Cycle 2 to Cycle 6 Day 1 (Each cycle is 28 days), End of treatment visit (up to 6 months from treatment initiation), and up to 18 months from treatment initiation
Overall survival rate
Overall survival frequency from initiation of study drug, including cause of death for patients who die on study
Measured: Through study completion, up to 18 months from treatment initiation
Frequency of Cytokine Release Syndrome (CRS)
Frequency of CRS (all-grade and grade ≥3) events
Measured: Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months)
Rate of infections
Frequency rate of infections (all-grade and grade ≥3) will be reported descriptively.
Measured: Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months)
Number of participants with a heart response after treatment
Heart response is defined as N-terminal pro Brain Natriuretic Peptide (NT-ProBNP) response (>30% and >300 ng/l decrease in subjects with baseline NT-proBNP>650 ng/l) or New York Heart Association (NYHA) class response (>2 class decrease in subjects with baseline NYHA class 3 or 4)
Measured: 6 months and 18 months
Number of No Responses in the heart after treatment
No response in the heart is defined as ≤30% reduction in NT-proBNP from baseline
Measured: 6 months and 18 months
Number of Partial Responses (PR) in participants who experienced a heart response after treatment
Partial Response in the heart is defined as 31-60% reduction in NT-proBNP from baseline.
Measured: 6 months and 18 months
Number of Very Good Partial Responses (VGPR) in participants who experienced a heart response after treatment
VGPR in the heart is defined as >60% reduction in NT-proBNP from baseline to a nadir of >350 ng/L
Measured: 6 months and 18 months
Number of Complete Response (CR) in participants who experienced a heart response after treatment
Complete Response in the heart is defined as Nadir NT-proBNP≤350 ng/L
Measured: 6 months and 18 months
Number of participants with heart progression after treatment
Heart progression is defined as NT-proBNP progression (>30% and >300 ng/l increase) or cardiac troponin progression (>33% increase) or ejection fraction progression (>10% decrease). Subjects with progressive worsening renal function cannot be scored for NT-proBNP progression.
Measured: 6 months and 18 months
Number of participants with a kidney response after treatment
Kidney response is defined as 50% decrease (at least 0.5 g/day) of 24-h urine protein (urine protein must be >0.5g/day pretreatment). Creatinine and creatinine clearance must not worsen by 25% over baseline.
Measured: 6 months and 18 months
Number of No Responses in the kidneys after treatment
No response in the kidneys is defined as ≤30% reduction in proteinuria from baseline
Measured: 6 months and 18 months
Number of Partial Responses (PR) in participants who experienced a kidney response after treatment
Partial Response in the kidneys is defined as 31-60% reduction in proteinuria from baseline
Measured: 6 months and 18 months
Number of Very Good Partial Responses (VGPR) in participants who experienced a kidney response after treatment
VGPR in the kidneys is defined as >60% reduction in proteinuria from baseline level to a nadir level >200 mg/24 hours
Measured: 6 months and 18 months
Number of Complete Response (CR) in participants who experienced a kidney response after treatment
Complete Response in the kidneys is defined as Nadir proteinuria ≤200 mg/24 hours
Measured: 6 months and 18 months
Number of participants with kidney progression after treatment
Kidney progression is defined as 50% increase (at least 1 g/day) of 24-h urine protein to >1 g/day or 25% worsening of serum creatinine or creatinine clearance.
Measured: 6 months and 18 months
Number of participants with liver response after treatment
Liver response is defined as 50% decrease in abnormal alkaline phosphatase value.
Measured: 6 months and 18 months
Number of No Responses in the liver after treatment
No response in the liver is defined as ≤30% reduction in alkaline phosphatase (ALP) from baseline.
Measured: 6 months and 18 months
Number of Partial Responses (PR) in participants who experienced liver response after treatment
Partial Response in the liver is defined as 31-60% reduction in ALP from baseline.
Measured: 6 months and 18 months
Number of Very Good Partial Responses (VGPR) in participants who experienced liver response after treatment
VGPR in the liver is defined as >60% reduction in ALP from baseline to a nadir >2x lower limit of normal (LLN)
Measured: 6 months and 18 months
Number of Complete Response (CR) in participants who experienced liver response after treatment
Complete Response in the liver is defined as Nadir ALP ≤2X LLN
Measured: 6 months and 18 months
Number of participants with liver progression after treatment
Liver progression is defined as 50% increase of ALP from nadir value
Measured: 6 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start7 Nov 2025
- Primary completionOct 2031 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloid Light-chain AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajshekhar Chakraborty, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor-investigator, Rajshekhar Chakraborty, MD, Columbia University
- Investigators
- Rajshekhar Chakraborty, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110844
- Sponsor's protocol ID
- AAAV8827
- Other IDs
- 1452862
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis
- ClinicalTrials.gov ID
- NCT07110844
- Acronym / sponsor ID
- AAAV8827
- Conditions
- Amyloid Light-chain Amyloidosis
- Keywords
- Untreated AL Amyloidosis, untreated light chain amyloidosis, light chain amyloidosis, AL Amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rajshekhar Chakraborty, MDUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2033 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis.
The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.
Detailed description
The purpose of this study is to assess the effectiveness and safety of teclistamab-daratumumab combination in newly diagnosed AL amyloidosis. The study aims to evaluate whether this combination is able to effectively decrease the level of toxic amyloid-producing light chains circulating in the participants' blood, with the overarching goal of avoiding organ damage, improving organ function, and prolonging life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teclistamab-Daratumumab | Experimental | Drug: Teclistamab, Drug: Daratumumab and Hyaluronidase-fihjAll participants in this study will receive teclistamab and daratumumab. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age >18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide informed consent due to medical, cognitive, or other conditions, a legally authorized representative (LAR) may consent on their behalf.
- Ability to comply with the study protocol, in the investigator's judgment.
- Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a tissue biopsy that is positive for Congo Red.
- Patient must not have received any prior plasma cell clone-directed therapy.
- Measurable hematologic disease, defined as one of the following:
Key exclusion criteria (14 listed)
- Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0.
- Patients meeting criteria for symptomatic multiple myeloma by any one of the following: (a) Lytic lesions on imaging (Skeletal survey, whole body CT or MRI, or PET/CT) (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, (d) Bone marrow plasma cell infiltrate of greater than 60%.
- Patients with involved/uninvolved serum FLC ratio>100 as the sole myeloma-defining event will be allowed.
- Evidence of significant cardiovascular conditions as specified below:
- History of other malignancy that could affect compliance with the protocol or interpretation of results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabAlso: TECVAYLI, teclistamab-cqyvTeclistamab is a T-cell redirecting bispecific antibody (BsAb) targeting CD3 on T-cells and B-cell maturation antigen (BCMA) on plasma cells. | Drug | Teclistamab-Daratumumab |
| Daratumumab and Hyaluronidase-fihjAlso: DARZALEX FASPRO, DaratumumabDaratumumab is an monoclonal antibody that targets the CD38 protein on the surface of myeloma cells. | Drug | Teclistamab-Daratumumab |
Primary outcome
Hematologic Complete Response (Heme-CR) rate
Time frame: 6 months from treatment initiation
Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response.
25 secondary outcomes
Minimal Residual Disease (MRD) negativity rate by Free Light Chain Mass Spectrometry (FLC-MS) in serum
Time frame: 1 month, 3 months, 6 months, and 18 months
MRD-negativity rate by multiparameter flow cytometry (MFC) in bone marrow
Time frame: 6 months and 18 months
Time to heme-CR
Time frame: Day 1 of each cycle, and every 6 weeks after treatment cessation (up to 1 year)
Major organ deterioration-progression-free survival (MOD-PFS) rate
Time frame: From Cycle 2 to Cycle 6 Day 1 (Each cycle is 28 days), End of treatment visit (up to 6 months from treatment initiation), and up to 18 months from treatment initiation
Overall survival rate
Time frame: Through study completion, up to 18 months from treatment initiation
Frequency of Cytokine Release Syndrome (CRS)
Time frame: Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months)
Rate of infections
Time frame: Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months)
Number of participants with a heart response after treatment
Time frame: 6 months and 18 months
Number of No Responses in the heart after treatment
Time frame: 6 months and 18 months
Number of Partial Responses (PR) in participants who experienced a heart response after treatment
Time frame: 6 months and 18 months
Number of Very Good Partial Responses (VGPR) in participants who experienced a heart response after treatment
Time frame: 6 months and 18 months
Number of Complete Response (CR) in participants who experienced a heart response after treatment
Time frame: 6 months and 18 months
Number of participants with heart progression after treatment
Time frame: 6 months and 18 months
Number of participants with a kidney response after treatment
Time frame: 6 months and 18 months
Number of No Responses in the kidneys after treatment
Time frame: 6 months and 18 months
Number of Partial Responses (PR) in participants who experienced a kidney response after treatment
Time frame: 6 months and 18 months
Number of Very Good Partial Responses (VGPR) in participants who experienced a kidney response after treatment
Time frame: 6 months and 18 months
Number of Complete Response (CR) in participants who experienced a kidney response after treatment
Time frame: 6 months and 18 months
Number of participants with kidney progression after treatment
Time frame: 6 months and 18 months
Number of participants with liver response after treatment
Time frame: 6 months and 18 months
Number of No Responses in the liver after treatment
Time frame: 6 months and 18 months
Number of Partial Responses (PR) in participants who experienced liver response after treatment
Time frame: 6 months and 18 months
Number of Very Good Partial Responses (VGPR) in participants who experienced liver response after treatment
Time frame: 6 months and 18 months
Number of Complete Response (CR) in participants who experienced liver response after treatment
Time frame: 6 months and 18 months
Number of participants with liver progression after treatment
Time frame: 6 months and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajshekhar Chakraborty, MD principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teclistamab and Daratumumab and Hyaluronidase-fihj in people with Amyloid Light-chain Amyloidosis, run by Rajshekhar Chakraborty, MD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Central Nurse Navigator, RN ((212) 342 5162, cancerclinicaltrials@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic Complete Response (Heme-CR) rate (time frame: 6 months from treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.