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Chronic Myeloid LeukemiaPhase 2VARIANTNCT05701215

Venetoclax After TKI to Target Persisting Stem Cells in CML

A Phase 2 study testing Venetoclax in people with Chronic Myeloid Leukemia, run by Thomas Ernst, PD Dr. med. at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is currently no available treatment, capable to increase the rate of sustained deep molecular remissions after TKI discontinuation in CML. Venetoclax could be such a drug. The study will provide unprecedented biological insights on the effects of venetoclax in controlling minimal residual stem cell disease… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesGermany
Study dates
31 Aug 2023to 31 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Patients with diagnosis of chronic phase CML with cytogenetic confirmation of the Philadelphia (Ph) chromosome
  • Ph negative cases or patients with variant translocations who are BCR::ABL1 positive in multiplex PCR are also eligible
  • Typical b2a2 and/or b3a2 BCR::ABL1 transcripts
  • Subject must be ≥ 18 years of age
  • Stored DNA from initial diagnosis (prior TKI treatment) for BCR::ABL1 breakpoint analysis
  • BCR::ABL1 transcript level according to the international scale (IS) of MR4 or better which has been confirmed three times within the past 13 months and was assessed by an IS-certified reference laboratory, such as of the University Jena or another MR4-certified laboratory in Germany
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  • At least 3 years of TKI therapy
  • Patients who failed to discontinue TKI in a prior discontinuation attempt are still eligible if they fulfill criteria 6 after retreatment with TKI
  • WHO performance status 0-2
  • Adequate end organ function as defined by:
  • Total bilirubin (TBL) < 3 x Upper Limit of Normal (ULN); patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN,
  • Creatinine Clearance (CrCl) ≥ 30 millilitres per minute (mL/min) as calculated using Cockcroft-Gault formula, Serum lipase ≤ 1.5 x ULN. For serum lipase > ULN 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis.
  • Patients must have the following laboratory values within normal limits or corrected to within normal limits with supplements:
  • Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with CrCl ≥ 90 mL/min),
  • Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with CrCl ≥ 90 mL/min),
  • Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl ≥ 90 mL/min),
  • For patients with mild to moderate renal impairment (CrCl ≥ 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be within normal limits or corrected to within normal limits with supplements.
  • Women of childbearing age must use a highly effective method of contraception while using venetoclax. Women using hormonal contraceptives should also use a barrier method.
  • Negative pregnancy test in women of childbearing potential
  • Subject must voluntarily sign and date an informed consent

Who cannot join

  • Concomitant use of strong CYP3A-Inhibtors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) is contraindicated
  • Concomitant use of moderate CYP3A-Inhibitors (e.g., ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) should be avoided.
  • Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax as they contain inhibitors of CYP3A
  • Concomitant use of venetoclax with P-gp and BCRP inhibitors
  • Concomitant use of venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided
  • Concomitant use of preparations containing St. John´s wort
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  • Patients with severe renal impairment (Crea-Clearance < 30 ml/min) or on dialysis
  • Patients with severe hepatic impairment
  • Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to employ an effective barrier method of birth control throughout the study and for and for at least 30 days after ending venetoclax treatment
  • Known impaired cardiac function
  • Impaired gastrointestinal function or disease that may alter the absorption of study drug
  • Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Active or uncontrolled infections at the time of enrolment
  • Known HIV sero-positivity or known active hepatitis B or C infection (HIV testing is not required)
  • Participation in another clinical study with other investigational drugs within 14 days prior to enrolment
  • Any medical, mental, psychological or psychiatric condition that in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
  • Subject has acute leukemia
  • Subject has known active CNS involvement.
  • Hypersensitivity to venetoclax or any component of the formulation

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Uniklinik der RWTH Aachen

    Aachen, 52074

  • Universitätsklinikum Jena

    Jena, 07747

Other trials in Germany

About this study

There is currently no available treatment, capable to increase the rate of sustained deep molecular remissions after TKI discontinuation in CML. Venetoclax could be such a drug. The study will provide unprecedented biological insights on the effects of venetoclax in controlling minimal residual stem cell disease induced by long-term prior TKI therapy. If the study would be positive, the findings could become practice changing for patients in deep molecular remission under TKI and willing to tolerate a temporary additional treatment.

Being tested
Venetoclax
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

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

  • VenetoclaxDrug

    Venetoclax will be taken orally once daily (400 mg) for 12 months

Study groups in NCT05701215
Study groupRoleWhat they receive
VenetoclaxExperimentalVenetoclax will be taken orally once daily (400 mg) for 12 months after stop of TKI
Receives: Drug: Venetoclax

What is being measured

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

  1. stem cell change

    Reduction of BCR::ABL1 stem cells measured by quantitative genomic PCR in bone marrow after venetoclax administration.

    Measured: at 6 months and 12 months after start of Venetoclax

Secondary outcomes (3)

  1. European Organisation for Research and Treatment of Cancer - Quality of Life C30 - Questionnaire

    compared to baseline with EORTC-QLQ C30 - Questionnaire (Score from 1 to 4; 1 better, 4 worse)

    Measured: at 6 months and 12 months after start of Venetoclax

  2. Kinetics of BCR::ABL1-transcript expression

    Kinetics of typical BCR::ABL1 transcript level over time after Tyrosine kinase stop

    Measured: monthly after start of Venetoclax until month 12

  3. Overall survival (OS)

    defined as the time between the date of enrollment and the date of death from any cause.

    Measured: monthly after start of Venetoclax until month 12

Timeline

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

  1. First posted27 Jan 2023
  2. Study start31 Aug 2023
  3. Primary completion31 May 2026
  4. Study completion31 May 2026

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701215
Sponsor's protocol ID
VARIANT
Other IDs
2022-003069-39
Acronym
VARIANT
Status last verified
Aug 2026
First submitted
26 Oct 2022
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax in people with Chronic Myeloid Leukemia, run by Thomas Ernst, PD Dr. med. at 2 sites in Germany.

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 20 inclusion and 19 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: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

stem cell change (time frame: at 6 months and 12 months after start of Venetoclax). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701215.

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 18 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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